otite mÉdia aguda - oma pediatrics 2013

DOI: 10.1542/peds.2012-3488; originally published online February 25, 2013; 2013;131;e964Pediatrics

E. TunkelM. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and DavidAlejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, Richard

Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. Ganiats,The Diagnosis and Management of Acute Otitis Media

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of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Boulevard, Elk Grove Village, Illinois, 60007. Copyright 2013 by the American Academy published, and trademarked by the American Academy of Pediatrics, 141 Northwest Pointpublication, it has been published continuously since 1948. PEDIATRICS is owned, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

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DOI: 10.1542/peds.2012-3488; originally published online February 25, 2013; 2013;131;e964Pediatrics

E. TunkelM. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and DavidAlejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, Richard

Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. Ganiats,The Diagnosis and Management of Acute Otitis Media

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CLINICAL PRACTICE GUIDELINE

The Diagnosis and Management of Acute Otitis Media

abstractThis evidence-based clinical practice guideline is a revision of the 2004acute otitis media (AOM) guideline from the American Academy of Pe-diatrics (AAP) and American Academy of Family Physicians. It providesrecommendations to primary care clinicians for the management ofchildren from 6 months through 12 years of age with uncomplicatedAOM.

In 2009, the AAP convened a committee composed of primary carephysicians and experts in the elds of pediatrics, family practice, oto-laryngology, epidemiology, infectious disease, emergency medicine,and guideline methodology. The subcommittee partnered with theAgency for Healthcare Research and Quality and the Southern Califor-nia Evidence-Based Practice Center to develop a comprehensive reviewof the new literature related to AOM since the initial evidence report of2000. The resulting evidence report and other sources of data wereused to formulate the practice guideline recommendations.

The focus of this practice guideline is the appropriate diagnosis andinitial treatment of a child presenting with AOM. The guideline providesa specic, stringent denition of AOM. It addresses pain management,initial observation versus antibiotic treatment, appropriate choices ofantibiotic agents, and preventive measures. It also addresses recur-rent AOM, which was not included in the 2004 guideline. Decisions weremade on the basis of a systematic grading of the quality of evidenceand benet-harm relationships.

The practice guideline underwent comprehensive peer review beforeformal approval by the AAP.

This clinical practice guideline is not intended as a sole source of guid-ance in the management of children with AOM. Rather, it is intended toassist primary care clinicians by providing a framework for clinicaldecision-making. It is not intended to replace clinical judgment or es-tablish a protocol for all children with this condition. These recommend-ations may not provide the only appropriate approach to themanagement of this problem. Pediatrics 2013;131:e964e999

Allan S. Lieberthal, MD, FAAP, Aaron E. Carroll, MD, MS,FAAP, Tasnee Chonmaitree, MD, FAAP, Theodore G. Ganiats,MD, Alejandro Hoberman, MD, FAAP, Mary Anne Jackson,MD, FAAP, Mark D. Joffe, MD, FAAP, Donald T. Miller, MD,MPH, FAAP, Richard M. Rosenfeld, MD, MPH, FAAP, Xavier D.Sevilla, MD, FAAP, Richard H. Schwartz, MD, FAAP, Pauline A.Thomas, MD, FAAP, and David E. Tunkel, MD, FAAP, FACS

KEY WORDSacute otitis media, otitis media, otoscopy, otitis media witheffusion, watchful waiting, antibiotics, antibiotic prophylaxis,tympanostomy tube insertion, immunization, breastfeeding

ABBREVIATIONSAAFPAmerican Academy of Family PhysiciansAAPAmerican Academy of PediatricsAHRQAgency for Healthcare Research and QualityAOMacute otitis mediaCIcondence intervalFDAUS Food and Drug AdministrationLAIVlive-attenuated intranasal inuenza vaccineMEEmiddle ear effusionMICminimum inhibitory concentrationNNTnumber needed to treatOMotitis mediaOMEotitis media with effusionORodds ratioPCV7heptavalent pneumococcal conjugate vaccinePCV1313-valent pneumococcal conjugate vaccineRDrate differenceSNAPsafety-net antibiotic prescriptionTIVtrivalent inactivated inuenza vaccineTMtympanic membraneWASPwait-and-see prescription

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authorshave led conict of interest statements with the AmericanAcademy of Pediatrics. Any conicts have been resolved througha process approved by the Board of Directors. The AmericanAcademy of Pediatrics has neither solicited nor accepted anycommercial involvement in the development of the content ofthis publication.

The recommendations in this report do not indicate an exclusivecourse of treatment or serve as a standard of medical care.Variations, taking into account individual circumstances, may beappropriate.

(Continued on last page)

e964 FROM THE AMERICAN ACADEMY OF PEDIATRICS

Organizational Principles to Guide and Dene the ChildHealth Care System and/or Improve the Health of all Children

Key Action Statement 1A: Cliniciansshould diagnose acute otitis media(AOM) in children who present withmoderate to severe bulging of thetympanic membrane (TM) or newonset of otorrhea not due to acuteotitis externa. Evidence Quality:Grade B. Strength: Recommendation.

Key Action Statement 1B: Cliniciansshould diagnose AOM in childrenwho present with mild bulging of theTM and recent (less than 48 hours)onset of ear pain (holding, tugging,rubbing of the ear in a nonverbalchild) or intense erythema ofthe TM. Evidence Quality: Grade C.Strength: Recommendation.

Key Action Statement 1C: Cliniciansshould not diagnose AOM in chil-dren who do not have middle eareffusion (MEE) (based on pneu-matic otoscopy and/or tympanometry).Evidence Quality: Grade B. Strength:Recommendation.

Key Action Statement 2: The man-agement of AOM should include anassessment of pain. If pain ispresent, the clinician should rec-ommend treatment to reduce pain.Evidence Quality: Grade B. Strength:Strong Recommendation.

Key Action Statement 3A: SevereAOM: The clinician should prescribeantibiotic therapy for AOM (bilateralor unilateral) in children 6 monthsand older with severe signs orsymptoms (ie, moderate or severeotalgia or otalgia for at least 48hours or temperature 39C [102.2F]or higher). Evidence Quality: Grade B.Strength: Strong Recommendation.

Key Action Statement 3B: Non-severe bilateral AOM in youngchildren: The clinician should pre-scribe antibiotic therapy for bi-lateral AOM in children 6 monthsthrough 23 months of age withoutsevere signs or symptoms (ie, mildotalgia for less than 48 hours and

temperature less than 39C [102.2F]).Evidence Quality: Grade B. Strength:Recommendation.

Key Action Statement 3C: Non-severe unilateral AOM in youngchildren: The clinician should ei-ther prescribe antibiotic therapyor offer observation with closefollow-up based on joint decision-making with the parent(s)/caregiverfor unilateral AOM in children 6months to 23 months of age withoutsevere signs or symptoms (ie, mildotalgia for less than 48 hoursand temperature less than 39C[102.2F]). When observation isused, a mechanism must be in placeto ensure follow-up and begin anti-biotic therapy if the child worsensor fails to improve within 48 to72 hours of onset of symptoms.Evidence Quality: Grade B. Strength:Recommendation.

Key Action Statement 3D: NonsevereAOM in older children: The clinicianshould either prescribe antibiotictherapy or offer observation withclose follow-up based on jointdecision-making with the parent(s)/caregiver for AOM (bilateral or uni-lateral) in children 24 months orolder without severe signs orsymptoms (ie, mild otalgia for lessthan 48 hours and temperature lessthan 39C [102.2F]). When obser-vation is used, a mechanism mustbe in place to ensure follow-up andbegin antibiotic therapy if the childworsens or fails to improve within48 to 72 hours of onset of symptoms.Evidence Quality: Grade B. Strength:Recommendation.

Key Action Statement 4A: Cliniciansshould prescribe amoxicillin forAOM when a decision to treat withantibiotics has been made and thechild has not received amoxicillin inthe past 30 days or the child doesnot have concurrent purulent con-junctivitis or the child is not allergic

to penicillin. Evidence Quality: GradeB. Strength: Recommendation.

Key Action Statement 4B: Cliniciansshould prescribe an antibiotic withadditional -lactamase coveragefor AOM when a decision to treatwith antibiotics has been made,and the child has received amoxi-cillin in the last 30 days or hasconcurrent purulent conjunctivitis,or has a history of recurrent AOMunresponsive to amoxicillin. Evi-dence Quality: Grade C. Strength:Recommendation.

Key Action Statement 4C: Cliniciansshould reassess the patient if thecaregiver reports that the childssymptoms have worsened or failedto respond to the initial antibiotictreatment within 48 to 72 hoursand determine whether a changein therapy is needed. EvidenceQuality: Grade B. Strength: Recom-mendation.

Key Action Statement 5A: Cliniciansshould not prescribe prophylacticantibiotics to reduce the frequencyof episodes of AOM in children withrecurrent AOM. Evidence Quality:Grade B. Strength: Recommendation.

Key Action Statement 5B: Cliniciansmay offer tympanostomy tubes forrecurrent AOM (3 episodes in 6months or 4 episodes in 1 yearwith 1 episode in the preceding6 months). Evidence Quality: GradeB. Strength: Option.

Key Action Statement 6A: Cliniciansshould recommend pneumococcalconjugate vaccine to all childrenaccording to the schedule of theAdvisory Committee on Immuniza-tion Practices of the Centers forDisease Control and Prevention,American Academy of Pediatrics(AAP), and American Academy ofFamily Physicians (AAFP). EvidenceQuality: Grade B. Strength: StrongRecommendation.

PEDIATRICS Volume 131, Number 3, March 2013 e965

FROM THE AMERICAN ACADEMY OF PEDIATRICS

Key Action Statement 6B: Cliniciansshould recommend annual inuenzavaccine to all children according tothe schedule of the Advisory Com-mittee on Immunization Practices,AAP, and AAFP. Evidence Quality:Grade B. Strength: Recommendation.

2Key Action Statement 6C: Cliniciansshould encourage exclusive breast-feeding for at least 6 months. Evi-dence Quality: Grade B. Strength:Recommendation.

Key Action Statement 6D: Cliniciansshould encourage avoidance of to-bacco smoke exposure. EvidenceQuality: Grade C. Strength: Recom-mendation.

INTRODUCTION

In May 2004, the AAP and AAFP pub-lished the Clinical Practice Guideline:Diagnosis and Management of AcuteOtitis Media.1 The guideline offered8 recommendations ranked accord-ing to level of evidence and benet-harm relationship. Three of therecommendationsdiagnostic criteria,observation, and choice of antibioticsled to signicant discussion, especiallyamong experts in the eld of otitis me-dia (OM). Also, at the time the guidelinewas written, information regarding theheptavalent pneumococcal conjugatevaccine (PCV7) was not yet published.Since completion of the guideline inNovember 2003 and its publication inMay 2004, there has been a signicantbody of additional literature on AOM.

Although OM remains the most commoncondition for which antibacterial agentsare prescribed for children in the UnitedStates2,3 clinician visits for OM de-creased from 950 per 1000 children in19951996 to 634 per 1000 children in20052006. There has been a pro-portional decrease in antibiotic pre-scriptions for OM from 760 per 1000in 19951996 to 484 per 1000 in20052006. The percentage of OM visits

resulting in antibiotic prescriptionsremained relatively stable (80% in 19951996; 76% in 20052006).2 Many factorsmay have contributed to the decreasein visits for OM, including nancialissues relating to insurance, such ascopayments, that may limit doctor visits,public education campaigns regardingthe viral nature of most infectious dis-eases, use of the PCV7 pneumococcalvaccine, and increased use of theinuenza vaccine. Clinicians may also bemore attentive to differentiating AOMfrom OM with effusion (OME), resultingin fewer visits coded for AOM andfewer antibiotic prescriptions written.

Despite signicant publicity andawareness of the 2004 AOM guideline,evidence shows that clinicians arehesitant to follow the guideline recom-mendations. Vernacchio et al4 surveyed489 primary care physicians as to theirmanagement of 4 AOM scenariosaddressed in the 2004 guideline. Nosignicant changes in practice werenoted on this survey, compared witha survey administered before the 2004AOM guideline. Coco5 used the NationalAmbulatory Medical Care Survey from2002 through 2006 to determine thefrequency of AOM visits without anti-biotics before and after publication ofthe 2004 guideline. There was no dif-ference in prescribing rates. A similarresponse to otitis guidelines was foundin Italy as in the United States.6,7

These ndings parallel results of otherinvestigations regarding clinician aware-ness and adherence to guidelinerecommendations in all specialties,including pediatrics.8 Clearly, for clin-ical practice guidelines to be effective,more must be done to improve theirdissemination and implementation.

This revision and update of the AAP/AAFP2004 AOM guideline1 will evaluate pub-lished evidence on the diagnosis andmanagement of uncomplicated AOMand make recommendations based onthat evidence. The guideline is intended

for primary care clinicians includingpediatricians and family physicians,emergency department physicians,otolaryngologists, physician assistants,and nurse practitioners. The scopeof the guideline is the diagnosisand management of AOM, includingrecurrent AOM, in children 6 monthsthrough 12 years of age. It applies onlyto an otherwise healthy child withoutunderlying conditions that may alterthe natural course of AOM, includingbut not limited to the presence oftympanostomy tubes; anatomic abnor-malities, including cleft palate; geneticconditions with craniofacial abnormali-ties, such as Down syndrome; immunedeciencies; and the presence of co-chlear implants. Children with OMEwithout AOM are also excluded.

Glossary of Terms

AOMthe rapid onset of signs andsymptoms of inammation in themiddle ear9,10

Uncomplicated AOMAOM withoutotorrhea1

Severe AOMAOM with the presenceof moderate to severe otalgia or feverequal to or higher than 39C9,10

Nonsevere AOMAOM with thepresence of mild otalgia and a tem-perature below 39C9,10

Recurrent AOM3 or more well-documented and separate AOM epi-sodes in the preceding 6 months or4 or more episodes in the preceding12 months with at least 1 episode inthe past 6 months11,12

OMEinammation of the middle earwith liquid collected in the middle ear;the signs and symptoms of acute in-fection are absent9

MEEliquid in the middle ear withoutreference to etiology, pathogenesis,pathology, or duration9

Otorrheadischarge from the ear,originating at 1 or more of the follow-ing sites: the external auditory canal,


middle ear, mastoid, inner ear, or in-tracranial cavity

Otitis externaan infection of theexternal auditory canal

Tympanometrymeasuring acousticimmittance (transfer of acoustic en-ergy) of the ear as a function of earcanal air pressure13,14

Number needed to treat (NNT)thenumber of patients who need to betreated to prevent 1 additional badoutcome15

Initial antibiotic therapytreatmentof AOM with antibiotics that are pre-scribed at the time of diagnosis with theintent of starting antibiotic therapy assoon as possible after the encounter

Initial observationinitial manage-ment of AOM limited to symptomaticrelief, with commencement of antibiotictherapy only if the childs conditionworsens at any time or does not showclinical improvement within 48 to 72hours of diagnosis; a mechanism mustbe in place to ensure follow-up andinitiation of antibiotics if the child failsobservation

METHODS

Guideline development using anevidence-based approach requiresthat all evidence related to theguideline is gathered in a systematicfashion, objectively assessed, and thendescribed so readers can easily seethe links between the evidence andrecommendations made. An evidence-based approach leads to recom-mendations that are guided by boththe quality of the available evidenceand the benet-to-harm ratio thatresults from following the recom-mendation. Figure 1 shows the re-lationship of evidence quality andbenet-harm balance in determiningthe level of recommendation. Table 1presents the AAP denitions andimplications of different levels ofevidence-based recommendations.16

In preparing for the 2004 AAP guide-lines, the Agency for Healthcare Re-search and Quality (AHRQ) funded andconducted an exhaustive review of theliterature on diagnosis and manage-ment of AOM.1719 In 2008, the AHRQ andthe Southern California Evidence-BasedPractice Center began a similar pro-cess of reviewing the literature pub-lished since the 2001 AHRQ report. TheAAP again partnered with AHRQ andthe Southern California Evidence-BasedPractice Center to develop the evi-dence report, which served as a majorsource of data for these practiceguideline recommendations.20,21 Newkey questions were determined bya technical expert panel. The scope ofthe new report went beyond the 2001AHRQ report to include recurrent AOM.

The key questions addressed by AHRQin the 2010 report were as follows:

1. Diagnosis of AOM: What are the op-erating characteristics (sensitivity,specicity, and likelihood ratios) ofclinical symptoms and otoscopicndings (such as bulging TM) todiagnose uncomplicated AOM andto distinguish it from OME?

2. What has been the effect of the useof heptavalent PCV7 on AOM micro-bial epidemiology, what organisms(bacterial and viral) are associatedwith AOM since the introduction ofPCV7, and what are the patterns

of antimicrobial resistance in AOMsince the introduction of PCV7?

3. What is the comparative effective-ness of various treatment optionsfor treating uncomplicated AOM inaverage risk children?

4. What is the comparative effectivenessof different management options forrecurrent OM (uncomplicated) andpersistent OM or relapse of AOM?

5. Do treatment outcomes in Ques-tions 3 and 4 differ by character-istics of the condition (AOM), patient,environment, and/or health care de-livery system?

6. What adverse effects have been ob-served for treatments for whichoutcomes are addressed in Ques-tions 3 and 4?

For the 2010 review, searches of PubMedand the Cochrane Database of System-atic Reviews, Cochrane Central Registerof Controlled Trials, and EducationResources Information Center wereconducted by using the same searchstrategies used for the 2001 report forpublications from 1998 through June2010. Additional terms or conditions notconsidered in the 2001 review (recurrentOM, new drugs, and heptavalent pneu-mococcal vaccine) were also included.The Web of Science was also used tosearch for citations of the 2001 reportand its peer-reviewed publications. Titleswere screened independently by 2

FIGURE 1Relationship of evidence quality and benet-harm balance in determining the level of recommen-dation. RCT, randomized controlled trial.



pediatricians with experience in con-ducting systematic reviews.

For the question pertaining to diagnosis,efcacy, and safety, the search wasprimarily for clinical trials. For thequestion pertaining to the effect of PCV7on epidemiology and microbiology, thegroup searched for trials that comparedmicrobiology in the same populationsbefore and after introduction of thevaccine or observational studies thatcompared microbiology across vacci-nated and unvaccinated populations.

In total, the reviewers examined 7646titles, of which 686 titles were identiedfor further review. Of those, 72 articlesthat met the predetermined inclusionand exclusion criteria were reviewed indetail. Investigators abstracted datainto standard evidence tables, withaccuracy checked by a second in-vestigator. Studies were quality-ratedby 2 investigators by using estab-lished criteria. For randomized con-trolled trials, the Jadad criteria wereused.22 QUADAS criteria23 were used toevaluate the studies that pertained todiagnosis. GRADE criteria were appliedto pooled analyses.24 Data abstracted

included parameters necessary to de-ne study groups, inclusion/exclusioncriteria, inuencing factors, and out-come measures. Some of the data foranalysis were abstracted by a bio-statistician and checked by a physicianreviewer. A sequential resolution strat-egy was used to match and resolve thescreening and review results of the2 pediatrician reviewers.

For the assessment of treatment ef-cacy, pooled analyses were performedfor comparisons for which 3 or moretrials could be identied. Studies eligi-ble for analyses of questions pertainingto treatment efcacy were grouped forcomparisons by treatment options. Eachcomparison consisted of studies thatwere considered homogeneous acrossclinical practice. Because some of thekey questions were addressed in the2001 evidence report,17 studies identi-ed in that report were included withnewly identied articles in the 2010evidence report.20

Decisions were made on the basis ofa systematic grading of the quality of ev-idence and strength of recommendationsas well as expert consensus when

denitive data were not available.Results of the literature review werepresented in evidence tables and pub-lished in the nal evidence report.20

In June 2009, the AAP convened a newsubcommittee to review and revise theMay 2004 AOM guideline.1 The sub-committee comprised primary carephysicians and experts in the elds ofpediatrics, family practice, otolaryn-gology, epidemiology, infectious dis-ease, emergency medicine, andguideline methodology. All panelmembers reviewed the AAP policy onconict of interest and voluntary dis-closure and were given an opportu-nity to present any potential conictswith the subcommittees work. All po-tential conicts of interest are listedat the end of this document. The projectwas funded by the AAP. New literatureon OM is continually being published.Although the systematic review per-formed by AHRQ could not be repli-cated with new literature, membersof the Subcommittee on Diagnosisand Management of Acute Otitis Mediareviewed additional articles. PubMedwas searched by using the singlesearch term acute otitis media,

TABLE 1 Guideline Denitions for Evidence-Based Statements

Statement Denition Implication

Strong Recommendation A strong recommendation in favor of a particular action is madewhen the anticipated benets of the recommendedintervention clearly exceed the harms (as a strongrecommendation against an action is made when theanticipated harms clearly exceed the benets) and the qualityof the supporting evidence is excellent. In some clearlyidentied circumstances, strong recommendations may bemade when high-quality evidence is impossible to obtain andthe anticipated benets strongly outweigh the harms.

Clinicians should follow a strong recommendation unlessa clear and compelling rationale for an alternative approachis present.

Recommendation A recommendation in favor of a particular action is made whenthe anticipated benets exceed the harms, but the quality ofevidence is not as strong. Again, in some clearly identiedcircumstances, recommendations may be made when high-quality evidence is impossible to obtain but the anticipatedbenets outweigh the harms.

Clinicians would be prudent to follow a recommendation butshould remain alert to new information and sensitive topatient preferences.

Option Options dene courses that may be taken when either thequality of evidence is suspect or carefully performed studieshave shown little clear advantage to 1 approach over another.

Clinicians should consider the option in their decision-making,and patient preference may have a substantial role.

No Recommendation No recommendation indicates that there is a lack of pertinentpublished evidence and that the anticipated balance ofbenets and harms is presently unclear.

Clinicians should be alert to new published evidence thatclaries the balance of benet versus harm.


approximately every 6 months fromJune 2009 through October 2011 toobtain new articles. Subcommitteemembers evaluated pertinent articlesfor quality of methodology and im-portance of results. Selected articlesused in the AHRQ review were alsoreevaluated for their quality. Con-clusions were based on the consensusof the subcommittee after the reviewof newer literature and reevaluation ofthe AHRQ evidence. Key action state-ments were generated using BRIDGE-Wiz(Building Recommendations in a Devel-opers Guideline Editor), an interactivesoftware tool that leads guideline de-velopment through a series of questionsthat are intended to create a more ac-tionable set of key action statements.25

BRIDGE-Wiz also incorporates the qualityof available evidence into the nal de-termination of the strength of eachrecommendation.

After thorough review by the sub-committee for this guideline, a draftwas reviewed by other AAP committeesand sections, selected outside organ-izations, and individuals identiedby the subcommittee as experts inthe eld. Additionally, members ofthe subcommittee were encouraged todistribute the draft to interested par-ties in their respective specialties. Allcomments were reviewed by the writ-ing group and incorporated into thenal guideline when appropriate.

This clinical practice guideline is notintended as a sole source of guidancein the management of children withAOM. Rather, it is intended to assistclinicians in decision-making. It is notintended to replace clinical judgmentor establish a protocol for the careof all children with this condition.These recommendations may notprovide the only appropriate approachto the management of children withAOM.

It is AAP policy to review and updateevidence-based guidelines every 5 years.

KEY ACTION STATEMENTSKey Action Statement 1A

Clinicians should diagnose AOM inchildren who present with moderate

to severe bulging of the TM or newonset of otorrhea not due to acute

otitis externa. (Evidence Quality: Grade

B, Rec. Strength: Recommendation)

Key Action Statement 1B

Clinicians should diagnose AOM inchildren who present with mildbulging of the TM and recent (lessthan 48 hours) onset of ear pain

(holding, tugging, rubbing of theear in a nonverbal child) or intenseerythema of the TM. (EvidenceQuality: Grade C, Rec. Strength:Recommendation)

Key Action Statement Prole: KAS 1AAggregate evidence quality Grade B

Benets Identify a population of children most likely to benet fromintervention.

Avoid unnecessary treatment of those without highly certainAOM.

Promote consistency in diagnosis.Risks, harms, cost May miss AOM that presents with a combination of mild bulging,

intense erythema, or otalgia that may not necessarilyrepresent less severe disease and may also benet fromintervention.

Benets-harms assessment Preponderance of benet.Value judgments Identication of a population of children with highly certain AOM

is benecial. Accurate, specic diagnosis is helpful to theindividual patient. Modication of current behavior ofoverdiagnosis is a goal. Increased specicity is preferredeven as sensitivity is lowered.

Intentional vagueness By using stringent diagnostic criteria, the TM appearance of lesssevere illness that might be early AOM has not beenaddressed.

Role of patient preferences NoneExclusions NoneStrength RecommendationNotes Tympanocentesis studies conrm that using these diagnostic

ndings leads to high levels of isolation of pathogenicbacteria. Evidence is extrapolated from treatment studiesthat included tympanocentesis.

Key Action Statement Prole: KAS 1BAggregate evidence quality Grade C

Benets Identify AOM in children when the diagnosis is not highlycertain.

Risks, harms, cost Overdiagnosis of AOM. Reduced precision in diagnosis.Benets-harms assessment Benets greater than harms.Value judgments None.Intentional vagueness Criteria may be more subjective.Role of patient preferences NoneExclusions NoneStrength RecommendationNotes Recent onset of ear pain means within the past 48 hours.



Key Action Statement 1C

Clinicians should not diagnose AOM inchildren who do not have MEE (based

on pneumatic otoscopy and/or tym-panometry). (Evidence Quality: Grade

B, Rec. Strength: Recommendation)

Purpose of This Section

There is no gold standard for the di-agnosis of AOM. In fact, AOM hasa spectrum of signs as the diseasedevelops.26 Therefore, the purpose ofthis section is to provide cliniciansand researchers with a working clin-ical denition of AOM and to differ-entiate AOM from OME. The criteriawere chosen to achieve high specic-ity recognizing that the resulting de-creased sensitivity may exclude lesssevere presentations of AOM.

Changes From AAP/AAFP 2004 AOMGuideline

Accurate diagnosis of AOM is critical tosound clinical decision-making andhigh-quality research. The 2004 Clin-ical Practice Guideline: Diagnosis andManagement of AOM1 used a 3-partdenition for AOM: (1) acute onset ofsymptoms, (2) presence of MEE, and(3) signs of acute middle ear in-ammation. This denition generatedextensive discussion and reanalysis ofthe AOM diagnostic evidence. The 2004denition lacked precision to excludecases of OME, and diagnoses of AOM

could be made in children with acuteonset of symptoms, including severeotalgia and MEE, without other otoscopicndings of inammation.27 Further-more, the use of uncertain dia-gnosis in the 2004 AOM guideline mayhave permitted diagnoses of AOMwithout clear visualization of the TM.Earlier studies may have enrolledchildren who had OME rather thanAOM, resulting in the possible classi-cation of such children as improvedbecause their nonspecic symptomswould have abated regardless oftherapy.2830 Two studies, published in2011, used stringent diagnostic crite-ria for diagnosing AOM with muchless risk of conclusions based on datafrom mixed patients.31,32

Since publication of the 2004 AOMguideline, a number of studies havebeen conducted evaluating scales forthe presence of symptoms. Thesestudies did not show a consistentcorrelation of symptoms with the ini-tial diagnosis of AOM, especially inpreverbal children.3335

Recent research has used preciselystated stringent criteria of AOM for

purposes of the studies.31,32 The currentguideline endorses stringent otoscopicdiagnostic criteria as a basis for man-agement decisions (described later). Asclinicians use the proposed stringentcriteria to diagnose AOM, they shouldbe aware that children with AOM mayalso present with recent onset of earpain and intense erythema of the TMas the only otoscopic nding.

Symptoms

Older children with AOM usuallypresent with a history of rapid onset ofear pain. However, in young preverbalchildren, otalgia as suggested bytugging/rubbing/holding of the ear,excessive crying, fever, or changes inthe childs sleep or behavior patternas noted by the parent are often rel-atively nonspecic symptoms. A num-ber of studies have attempted tocorrelate symptom scores with di-agnoses of AOM.

A systematic review36 identied 4articles that evaluated the accuracyof symptoms.3740 Ear pain appeareduseful in diagnosing AOM (combinedpositive likelihood ratio 3.07.3, nega-tive likelihood ratio 0.40.6); however,it was only present in 50% to 60% ofchildren with AOM. Conclusions fromthese studies may be limited, becausethey (1) enrolled children seen byspecialists, not likely to represent thewhole spectrum of severity of illness;(2) used a clinical diagnosis of AOMbased more on symptomatology ratherthan on tympanocentesis; and (3) in-cluded relatively older children.37,40

Laine et al34 used a questionnaireadministered to 469 parents whosuspected their children, aged 6 to 35months, had AOM. Of the children, 237had AOM using strict otoscopic crite-ria, and 232 had upper respiratorytract infection without AOM. Restlesssleep, ear rubbing, fever, and non-specic respiratory or gastrointestinal

Key Action Statement Prole: KAS 1CAggregate evidence quality Grade B

Benets Reduces overdiagnosis and unnecessary treatment. Increasescorrect diagnosis of other conditions with symptoms thatotherwise might be attributed to AOM. Promotes the use ofpneumatic otoscopy and tympanometry to improvediagnostic accuracy.

Risks, harms, cost Cost of tympanometry. Need to acquire or reacquire skills inpneumatic otoscopy and tympanometry for some clinicians.

Benets-harms assessment Preponderance of benet.Value judgments AOM is overdiagnosed, often without adequate visualization of

the TM. Early AOM without effusion occurs, but the risk ofoverdiagnosis supersedes that concern.

Intentional vagueness NoneRole of patient preferences NoneExclusions Early AOM evidenced by intense erythema of the TM.Strength Recommendation


tract symptoms did not differentiatechildren with or without AOM.

McCormick et al30 used 2 symptomscoresa 3-item score (OM-3), con-sisting of symptoms of physical suffer-ing such as ear pain or fever, emotionaldistress (irritability, poor appetite), andlimitation in activity; and a 5-item score(Ear Treatment Group Symptom Ques-tionnaire, 5 Items [ETG-5]), includingfever, earache, irritability, decreasedappetite, and sleep disturbancetoassess AOM symptoms at the time ofdiagnosis and daily during the 10-daytreatment or observation period. Theyfound both to be a responsive measureof changes in clinical symptoms. Thesame group35 also tested a visual scale,Acute Otitis Media-Faces Scale (AOM-FS),with faces similar to the Wong-Bakerpain scale.41 None of the scales wereadequately sensitive for making the di-agnosis of AOM based on symptoms. TheAOM-FS combined with an otoscopy score,OS-8,30 were presented as a double-sidedpocket card. The combination of AOM-FSand OS-8 was more responsive to changethan either instrument alone.

Shaikh et al33,42 validated a 7-itemparent-reported symptom score (AcuteOtitis Media Severity of Symptom Scale[AOM-SOS]) for children with AOM, fol-lowing stringent guidance of the USFood and Drug Administration (FDA)on the development of patient-reportedoutcome scales. Symptoms includedear tugging/rubbing/holding, excessivecrying, irritability, difculty sleeping,decreased activity or appetite, andfever. AOM-SOS was correlated withotoscopic diagnoses (AOM, OME, andnormal middle ear status). AOM-SOSchanged appropriately in response toclinical change. Its day-to-day re-sponsiveness supports its usefulness infollowing AOM symptoms over time.

Signs of AOM

Few studies have evaluated the re-lationship of otoscopic ndings in AOM

and tympanocentesis. A study byKarma et al43 is often cited as the bestsingle study of otoscopic ndings inAOM. However, the study uses onlya symptom-based diagnosis of AOMplus the presence of MEE. Thus, chil-dren with acute upper respiratorytract infection symptoms and OMEwould have been considered to haveAOM. There also were signicant dif-ferences in ndings at the 2 centersthat participated in the study.

The investigators correlated TM color,mobility, and position with the pres-ence of middle ear uid obtained bytympanocentesis. At 2 sites in Finland(Tampere and Oulu), 2911 childrenwere followed from 6 months to 2.5years of age. A single otolaryngologistat Tampere and a single pediatrician atOulu examined subjects. Color, posi-tion, and mobility were recorded.Myringotomy and aspiration wereperformed if MEE was suspected.AOM was diagnosed if MEE was foundand the child had fever, earache, irri-tability, ear rubbing or tugging, si-multaneous other acute respiratorytract symptoms, vomiting, or di-arrhea. The presence or absence ofMEE was noted, but no analyses ofthe uid, including culture, were per-formed. Pneumatic otoscopic ndingswere classied as follows: colorhemorrhagic, strongly red, moderatelyred, cloudy or dull, slightly red, or nor-mal; positionbulging, retracted, ornormal; and mobilitydistinctly im-paired, slightly impaired, or normal.

For this analysis, 11 804 visits wereavailable. For visits with acute symp-toms, MEE was found in 84.9% and81.8% at the 2 sites at which the studywas performed. There were signi-cant differences among the results atthe 2 centers involved in the study.Table 2 shows specic data for eachnding.

The combination of a cloudy, bulgingTM with impaired mobility was the

best predictor of AOM using thesymptom-based diagnosis in this study.Impaired mobility had the highest sen-sitivity and specicity (approximately95% and 85%, respectively). Cloudi-ness had the next best combination ofhigh sensitivity (74%) and highspecicity (93%) in this study. Bulg-ing had high specicity (97%) butlower sensitivity (51%). A TM thatwas hemorrhagic, strongly red, ormoderately red also correlated withthe presence of AOM, and a TM thatwas only slightly red was not helpfuldiagnostically.

McCormick et al reported that a bulg-ing TM was highly associated with thepresence of a bacterial pathogen, withor without a concomitant viral patho-gen.44 In a small study, 31 children(40 ears) underwent myringotomy.45

Bulging TMs had positive bacterialcultures 75% of the time. Thepercentage of positive cultures fora pathogen increased to 80% if thecolor of the TM was yellow. The con-clusion is that moderate to severebulging of the TM represents the mostimportant characteristic in the di-agnosis of AOMa nding that has

TABLE 2 Otoscopic Findings in Children WithAcute Symptoms and MEEa

TM Finding inAcute VisitsWith MEE

Group I(Tampere,Finland), %

Group II(Oulo,

Finland), %

ColorDistinctly red 69.8 65.6Hemorrhagic 81.3 62.9Strongly red 87.7 68.1Moderately red 59.8 66.0Slightly red 39.4 16.7Cloudy 95.7 80.0Normal 1.7 4.9

PositionBulging 96.0 89Retracted 46.8 48.6Normal 32.1 22.2

MobilityDistinctly impaired 94.0 78.5Slightly impaired 59.7 32.8Normal 2.7 4.8

a Totals are greater than 100%, because each ear mayhave had different ndings.43



implications for clinical care, re-search, and education.

The committee recognized that there isa progression from the presence ofMEE to the bulging of the TM, and itis often difcult to differentiate thisequivocal appearance from the highlycertain AOM criteria advocated in thisguideline.26 As such, there is a role forindividualized diagnosis and manage-ment decisions. Examples of normal,mild bulging, moderate bulging, andsevere bulging can be seen in Fig 2.

Distinguishing AOM From OME

OME may occur either as the aftermathof an episode of AOM or as a conse-quence of eustachian tube dysfunctionattributable to an upper respiratorytract infection.46 However, OME mayalso precede and predispose to thedevelopment of AOM. These 2 forms ofOM may be considered segments ofa disease continuum.47 However, be-cause OME does not represent anacute infectious process that benetsfrom antibiotics, it is of utmost im-portance for clinicians to becomeprocient in distinguishing normalmiddle ear status from OME or AOM.Doing so will avoid unnecessary useof antibiotics, which leads to in-creased adverse effects of medicationand facilitates the development ofantimicrobial resistance.

Examination of the TM

Accurate diagnosis of AOM in infantsand young children may be difcult.

Symptoms may be mild or overlap withthose of an upper respiratory tractillness. The TM may be obscured bycerumen, and subtle changes in the TMmay be difcult to discern. Additionalfactors complicating diagnosis mayinclude lack of cooperation from thechild; less than optimal diagnosticequipment, including lack of a pneu-matic bulb; inadequate instrumentsfor clearing cerumen from the externalauditory canal; inadequate assistancefor restraining the child; and lack ofexperience in removing cerumen andperforming pneumatic otoscopy.

The pneumatic otoscope is the stan-dard tool used in diagnosing OM.Valuable also is a surgical head, whichgreatly facilitates cleaning cerumenfrom an infants external auditorycanal. Cerumen may be removed byusing a curette, gentle suction, or ir-rigation.48 The pneumatic otoscopeshould have a light source of suf-cient brightness and an air-tight sealthat permits application of positiveand negative pressure. In general,nondisposable specula achieve a bet-ter seal with less pain because ofa thicker, smoother edge and betterlight transmission properties. Thespeculum size should be chosen togently seal at the outer portion of theexternal auditory canal.

Pneumatic otoscopy permits assess-ment of the contour of the TM (normal,retracted, full, bulging), its color(gray, yellow, pink, amber, white, red,blue), its translucency (translucent,

semiopaque, opaque), and its mobility(normal, increased, decreased, ab-sent). The normal TM is translucent,pearly gray, and has a ground-glassappearance (Fig 2A). Specic land-marks can be visualized. They includethe short process and the manubriumof the malleus and the pars accida,located superiorly. These are easilyobserved and help to identify the po-sition of the TM. Inward movement ofthe TM on positive pressure in theexternal canal and outward move-ment on negative pressure shouldoccur, especially in the superior pos-terior quadrant. When the TM isretracted, the short process of themalleus becomes more prominent,and the manubrium appears short-ened because of its change in positionwithin the middle ear. Inward motionoccurring with positive pressure isrestricted or absent, because theTM is frequently as far inward asits range of motion allows. However,outward mobility can be visualizedwhen negative pressure is applied. Ifthe TM does not move perceptibly withapplications of gentle positive ornegative pressure, MEE is likely.Sometimes, the application of pres-sure will make an air-uid interfacebehind the TM (which is diagnostic ofMEE) more evident.49

Instruction in the proper evaluation ofthe childs middle ear status shouldbegin with the rst pediatric rotationin medical school and continuethroughout postgraduate training.50

FIGURE 2A, Normal TM. B, TM with mild bulging. C, TM with moderate bulging. D, TM with severe bulging. Courtesy of Alejandro Hoberman, MD.


Continuing medical education shouldreinforce the importance of, and re-train the clinician in, the use ofpneumatic otoscopy.51 Training toolsinclude the use of a video-otoscope inresidency programs, the use of Web-based educational resources,49,52 aswell as simultaneous or sequentialexamination of TMs with an expertotoscopist to validate ndings by usinga double headed or video otoscope.Tools for learning the ear examinationcan be found in a CD distributed by theJohns Hopkins University School ofMedicine and the Institute for Johns

Hopkins Nursing,53 also available athttp://www2.aap.org/sections/infectdis/video.cfm,54 and through a Web-basedprogram, ePROM: Enhancing Prociencyin Otitis Media.52

Key Action Statement 2

The management of AOM shouldinclude an assessment of pain. Ifpain is present, the clinicianshould recommend treatment toreduce pain. (Evidence Quality:Grade B, Rec. Strength: StrongRecommendation)


Pain is the major symptom of AOM. Thissection addresses and updates theliterature on treating otalgia.


Only 2 new articles directly addressthe treatment of otalgia. Both addresstopical treatment. The 2 new articlesare consistent with the 2004 guidelinestatement. The text of the 2004 guidelineis, therefore, reproduced here, with theaddition of discussion of the 2 newarticles. Table 3 has been updated toinclude the new references.

Treatment of Otalgia

Many episodes of AOM are associatedwith pain.55 Some children with OMEalso have ear pain. Although pain is

a common symptom in these ill-nesses, clinicians often see otalgia asa peripheral concern not requiringdirect attention.56 Pain associated

with AOM can be substantial in therst few days of illness and oftenpersists longer in young children.57

Antibiotic therapy of AOM does notprovide symptomatic relief in the rst24 hours5861 and even after 3 to 7days, there may be persistent pain,fever, or both in 30% of childrenyounger than 2 years.62 In contrast,analgesics do relieve pain associatedwith AOM within 24 hours63 andshould be used whether antibiotictherapy is or is not prescribed; theyshould be continued as long asneeded. The AAP published the policystatement The Assessment andManagement of Acute Pain in Infants,Children, and Adolescents64 to assistthe clinician in addressing pain in thecontext of illness. The management ofpain, especially during the rst 24hours of an episode of AOM, should beaddressed regardless of the use ofantibiotics.

Various treatments of otalgia havebeen used, but none has been wellstudied. The clinician should selecta treatment on the basis of a consid-eration of benets and risks and,wherever possible, incorporateparent/caregiver and patient prefer-ence (Table 3).

Key Action Statement Prole: KAS 2Aggregate evidence quality Grade B

Benets Relieves the major symptom of AOM.Risks, harms, cost Potential medication adverse effects. Variable efcacy of some

modes of treatment.Benets-harms assessment Preponderance of benet.Value judgments Treating pain is essential whether or not antibiotics are

prescribed.Intentional vagueness Choice of analgesic is not specied.Role of patient preferences Parents may assist in the decision as to what means of pain

relief they prefer.Exclusions Topical analgesics in the presence of a perforated TM.Strength Strong Recommendation

TABLE 3 Treatments for Otalgia in AOM

Treatment Modality Comments

Acetaminophen, ibuprofen63 Effective analgesia for mild to moderate pain.Readily available. Mainstay of pain managementfor AOM.

Home remedies (no controlled studiesthat directly address effectiveness)

May have limited effectiveness.

DistractionExternal application of heat or coldOil drops in external auditory canal

Topical agentsBenzocaine, procaine, lidocaine65,67,70 Additional, but brief, benet over acetaminophen

in patients older than 5 y.Naturopathic agents68 Comparable to amethocaine/phenazone drops in

patients older than 6 y.Homeopathic agents71,72 No controlled studies that directly address pain.Narcotic analgesia with codeine

or analogsEffective for moderate or severe pain. Requires

prescription; risk of respiratory depression, alteredmental status, gastrointestinal tract upset, andconstipation.

Tympanostomy/myringotomy73 Requires skill and entails potential risk.



Since the 2004 guideline was pub-lished, there have been only 2 signi-cant new articles.

Bolt et al reported in 2008 on a double-blind placebo-controlled trial at theAustralia Childrens Hospital emer-gency department conducted in20032004.65 They used a conveniencesample of children 3 to 17 years ofage diagnosed with AOM in the ED.They excluded children with perfora-tion of the TM, pressure-equalizingtube, allergy to local anesthetic orparacetamol, epilepsy, or liver, renal,or cardiac disease. Sixty-three eligiblechildren were randomized to receiveaqueous lidocaine or normal salineear drops up to 3 times in 24 hours.They demonstrated a statistically sig-nicant 50% reduction in reportedpain at 10 and 30 minutes but not at20 minutes after application of topicallidocaine, compared with normal sa-line. Complications were minimal: 3children reported some dizziness thenext day, and none reported tinnitus.A limitation was that some childrenhad received oral acetaminophen be-fore administration of ear drops.

A Cochrane review of topical analgesiafor AOM66 searched the Cochraneregister of controlled trials, random-ized controlled trials, or quasi-randomized controlled trials thatcompared otic preparations to pla-cebo or that compared 2 otic prepa-rations. It included studies of adultsand children, without TM perforation.

It identied 5 trials in children 3 to18 years of age. Two (including Boltet al,65 discussed above) comparedanesthetic drops and placebo at di-agnosis of AOM. In both studies, somechildren also received oral analgesics.Three studies compared anestheticear drops with naturopathic herbaldrops. Naturopathic drops were fa-vored 15 to 30 minutes afterinstallation, and 1 to 3 days afterdiagnosis, but the difference was notstatistically signicant. The Cochranegroup concluded that there is limitedevidence that ear drops are effectiveat 30 minutes and unclear if resultsfrom these studies are a result of thenatural course of illness, placebo ef-fect of receiving treatment, soothingeffect of any liquid in the ear, or thedrops themselves. Three of the stud-ies included in this review were citedin the 2004 AAP guideline6769 and the1 new paper by Bolt et al.65

Key Action Statement 3A

Severe AOM

The clinician should prescribe an-tibiotic therapy for AOM (bilateralor unilateral) in children 6 monthsand older with severe signs orsymptoms (ie, moderate or severeotalgia or otalgia for at least 48hours, or temperature 39C[102.2F] or higher). (EvidenceQuality: Grade B, Rec. Strength:Strong Recommendation)


Nonsevere Bilateral AOM in YoungChildren

The clinician should prescribe an-tibiotic therapy for bilateral AOM inchildren younger than 24 monthswithout severe signs or symptoms(ie, mild otalgia for less than 48hours, temperature less than 39C[102.2F]). (Evidence Quality: GradeB, Rec. Strength: Recommendation)


Nonsevere Unilateral AOM in YoungChildren

The clinician should either prescribeantibiotic therapy or offer obser-vation with close follow-up basedon joint decision-making with theparent(s)/caregiver for unilateralAOM in children 6 months to 23months of age without severesigns or symptoms (ie, mild otalgiafor less than 48 hours, tempera-ture less than 39C [102.2F]).When observation is used, a mech-anism must be in place to ensure


Benets Increased likelihood of more rapid resolution of symptoms.Increased likelihood of resolution of AOM.

Risks, harms, cost Adverse events attributable to antibiotics, such as diarrhea,diaper dermatitis, and allergic reactions. Overuse ofantibiotics leads to increased bacterial resistance. Cost ofantibiotics.

Benets-harms assessment Preponderance of benet over harm.Value judgments NoneRole of patient preference NoneIntentional vagueness NoneExclusions NoneStrength Strong Recommendation

Key Action Statement Prole: KAS3BAggregate evidencequality

Grade B

Benets Increased likelihood of morerapid resolution of symptoms.Increased likelihood ofresolution of AOM.

Risks, harms,cost

Adverse events attributable toantibiotics, such as diarrhea,diaper dermatitis, andallergic reactions. Overuseof antibiotics leads toincreased bacterial resistance.Cost of antibiotics.

Benets-harmsassessment

Preponderance of benet overharm.

Value judgments NoneRole of patient

preferenceNone

Intentionalvagueness

None

Exclusions NoneStrength Recommendation


follow-up and begin antibiotic ther-apy if the child worsens or fails toimprove within 48 to 72 hours of

onset of symptoms. (Evidence Qual-ity: Grade B, Rec. Strength: Recom-mendation)

Key Action Statement 3D

Nonsevere AOM in Older Children

The clinician should either pre-scribe antibiotic therapy or offerobservation with close follow-upbased on joint decision-making withthe parent(s)/caregiver for AOM(bilateral or unilateral) in children24 months or older without severesigns or symptoms (ie, mild otalgia

for less than 48 hours, tempera-ture less than 39C [102.2F]).When observation is used, a mecha-nism must be in place to ensurefollow-up and begin antibiotic ther-apy if the child worsens or failsto improve within 48 to 72 hoursof onset of symptoms. (EvidenceQuality: Grade B, Rec Strength:Recommendation)


The purpose of this section is to offerguidance on the initial management ofAOM by helping clinicians choose be-tween the following 2 strategies:

1. Initial antibiotic therapy, dened astreatment of AOM with antibioticsthat are prescribed at the time ofdiagnosis with the intent of start-ing antibiotic therapy as soon aspossible after the encounter.

2. Initial observation, dened as ini-tial management of AOM limitedto symptomatic relief, with com-mencement of antibiotic therapyonly if the childs condition wors-ens at any time or does not showclinical improvement within 48 to72 hours of diagnosis. A mecha-nism must be in place to ensurefollow-up and initiation of antibiot-ics if the child fails observation.

This section assumes that the clinicianhas made an accurate diagnosis ofAOM by using the criteria and strate-gies outlined earlier in this guideline.Another assumption is that a cleardistinction is made between the role ofanalgesics and antibiotics in providingsymptomatic relief for children withAOM.

Changes From Previous AOMGuideline

The AOM guideline published by theAAP and AAFP in 2004 proposed, for therst time in North America, an ob-servation option for selected childrenwith AOM, building on successfulimplementation of a similar policy inthe state of New York74 and the use ofa similar paradigm in many countriesin Europe. A common feature of bothapproaches was to prioritize initialantibiotic therapy according to di-agnostic certainty, with greaterreliance on observation when the di-agnosis was uncertain. In response tocriticism that allowing an uncertain

Key Action Statement Prole: KAS 3CAggregate evidence quality Grade B

Benets Moderately increased likelihood of more rapid resolution of symptomswith initial antibiotics. Moderately increased likelihood of resolutionof AOM with initial antibiotics.

Risks, harms, cost Adverse events attributable to antibiotics, such as diarrhea, diaperdermatitis, and allergic reactions. Overuse of antibiotics leads toincreased bacterial resistance. Cost of antibiotics.

Benets-harms assessment Moderate degree of benet over harm.Value judgments Observation becomes an alternative as the benets and harms

approach balance.Role of patient preference Joint decision-making with the family is essential before choosing

observation.Intentional vagueness Joint decision-making is highly variable from family to familyExclusions NoneStrength RecommendationNote In the judgment of 1 Subcommittee member (AH), antimicrobial

treatment of these children is preferred because of a preponderanceof benet over harm. AH did not endorse Key Action Statement 3C

Key Action Statement Prole: KAS 3DAggregate evidence quality Grade B

Benets Initial antibiotic treatment: Slightly increased likelihood of morerapid resolution of symptoms; slightly increased likelihood ofresolution of AOM. Initial observation: Decreased use of antibiotics;decreased adverse effects of antibiotics; decreased potential fordevelopment of bacterial resistance.

Risks, harms, cost Initial antibiotic treatment: Adverse events attributable to antibioticssuch as diarrhea, rashes, and allergic reactions. Overuse ofantibiotics leads to increased bacterial resistance. Initialobservation: Possibility of needing to start antibiotics in 48 to 72 hif the patient continues to have symptoms. Minimal risk of adverseconsequences of delayed antibiotic treatment. Potential increasedphone calls and doctor visits.

Benets-harms assessment Slight degree of benet of initial antibiotics over harm.Value judgments Observation is an option as the benets and harms approach balance.Role of patient preference Joint decision-making with the family is essential before choosing

observation.Intentional vagueness Joint decision-making is highly variable from family to family.Exclusions NoneStrength Recommendation.



diagnosis might condone incompletevisualization of the TM or allow in-appropriate antibiotic use, this cate-gory has been eliminated with greateremphasis now placed on maximizingdiagnostic accuracy for AOM.

Since the earlier AOM guideline waspublished, there has been substantialnew research on initial managementof AOM, including randomized con-trolled trials of antibiotic therapyversus placebo or no therapy,31,32,75

immediate versus delayed antibiotictherapy,30,76,77 or delayed antibioticwith or without a concurrent pre-scription.78 The Hoberman and Thtinenarticles are especially important asthey used stringent criteria for di-agnosing AOM.31,32 Systematic reviewshave been published on delayed anti-biotic therapy,79 the natural history ofAOM in untreated children,57 pre-dictive factors for antibiotic benets,62

and the effect of antibiotics onasymptomatic MEE after therapy.80

Observational studies provide addi-tional data on outcomes of initial ob-servation with delayed antibiotictherapy, if needed,81 and on the re-lationship of previous antibiotic ther-apy for AOM to subsequent acutemastoiditis.82,83

In contrast to the earlier AOM guide-line,1 which recommended antibiotictherapy for all children 6 months to 2years of age with a certain diagnosis,

the current guideline indicatesa choice between initial antibiotictherapy or initial observation in thisage group for children with unilat-eral AOM and mild symptoms butonly after joint decision-making withthe parent(s)/caregiver (Table 4).This change is supported by evidenceon the safety of observation ordelayed prescribing in young chil-dren.30,31,32,75,76,81 A mechanism mustbe in place to ensure follow-up andbegin antibiotics if the child failsobservation.

Importance of Accurate Diagnosis

The recommendations for manage-ment of AOM assume an accuratediagnosis on the basis of criteriaoutlined in the diagnosis section of thisguideline. Many of the studies sincethe 2004 AAP/AAFP AOM guideline1

used more stringent and well-denedAOM diagnostic denitions than werepreviously used. Bulging of the TMwas required for diagnosis of AOM formost of the children enrolled in themost recent studies.31,32 By using thecriteria in this guideline, clinicianswill more accurately distinguish AOMfrom OME. The management of OMEcan be found in guidelines written bythe AAP, AAFP, and American Academyof Otolaryngology-Head and NeckSurgery.84,85

Age, Severity of Symptoms,Otorrhea, and Laterality

Rovers et al62 performed a systematicsearch for AOM trials that (1) usedrandom allocation of children, (2) in-cluded children 0 to 12 years of agewith AOM, (3) compared antibioticswith placebo or no treatment, and (4)had pain or fever as an outcome. Theoriginal investigators were asked fortheir original data.

Primary outcome was pain and/orfever (>38C) at 3 to 7 days. The ad-verse effects of antibiotics were alsoanalyzed. Baseline predictors wereage

bilateral AOM in children 2 years,the RD was 12% (NNT = 9). Forotorrhea, the RD was 36% (NNT = 3).One child in the control group whodeveloped meningitis had receivedantibiotics beginning on day 2 be-cause of worsening status. Therewere no cases of mastoiditis.

In a Cochrane Review, Sanders et al59

identied 10 studies that met the fol-lowing criteria: (1) randomized con-trolled trial, (2) compared antibioticversus placebo or antibiotic versusobservation, (3) age 1 month to 15years, (4) reported severity and dura-tion of pain, (5) reported adverseevents, and (6) reported serious com-plications of AOM, recurrent attacks,and hearing problems. Studies wereanalyzed for risk of bias and assess-ment of heterogeneity. The studieswere the same as analyzed by Roverset al62 but included the 4 studies forwhich primary data were not availableto Rovers.60,61,90,91

The authors conclusions were thatantibiotics produced a small re-duction in the number of children withpain 2 to 7 days after diagnosis. Theyalso concluded that most casesspontaneously remitted with no com-plications (NNT = 16). Antibiotics weremost benecial in children youngerthan 2 years with bilateral AOM and inchildren with otorrhea.

Two recent studies only includedchildren younger than 3 years32 oryounger than 2 years.31 Both includedonly subjects in whom the diagnosisof AOM was certain. Both studies usedimprovement of symptoms and im-provement in the appearance of theTM in their denitions of clinical suc-cess or failure.

Hoberman et al31 conducted a random-ized, double-blind, placebo-controlledstudy of the efcacy of antimicrobialtreatment on AOM. The criteria forAOM were acute symptoms witha score of at least 3 on the AOM-SOS,

a validated symptom scale33,92; MEE;and moderate or marked bulging ofthe TM or slight bulging accompaniedby either otalgia or marked erythemaof the TM. They chose to use high-dose amoxicillin-clavulanate (90 mg/kg/day) as active treatment, because ithas the best oral antibiotic coveragefor organisms causing AOM. Includedin the study were 291 patients 6 to 23months of age: 144 in the antibioticgroup and 147 in the placebo group.The primary outcome measures werethe time to resolution of symptomsand the symptom burden over time.The initial resolution of symptoms (ie,the rst recording of an AOM-SOSscore of 0 or 1) was recordedamong the children who receivedamoxicillin-clavulanate in 35% by day2, 61% by day 4, and 80% by day 7.Among children who received placebo,an AOM-SOS score of 0 or 1 wasrecorded in 28% by day 2, 54% by day4, and 74% by day 7 (P = .14 for theoverall comparison). For sustainedresolution of symptoms (ie, the timeto the second of 2 successiverecordings of an AOM-SOS score of0 or 1), the corresponding valueswere 20% at day 2, 41% at day 4, and67% at day 7 with amoxicillin-clavulanate, compared with 14%,36%, and 53% with placebo (P = .04for the overall comparison). Thesymptom burden (ie, mean AOM-SOSscores) over the rst 7 days werelower for the children treated withamoxicillin-clavulanate than for thosewho received placebo (P = .02). Clini-cal failure at or before the 4- to 5-dayvisit was dened as either a lack ofsubstantial improvement in symp-toms, a worsening of signs on oto-scopic examination, or both, andclinical failure at the 10- to 12-day visitwas dened as the failure to achievecomplete or nearly complete resolu-tion of symptoms and of otoscopicsigns, without regard to the persis-tence or resolution of middle ear

effusion. Treatment failure occurred byday 4 to 5 in 4% of the antimicrobialtreatment group versus 23% in theplacebo group (P < .001) and at day10 to 12 in 16% of the antimicrobialtreatment group versus 51% in theplacebo group (NNT = 2.9, P < .001). Ina comparison of outcome in unilateralversus bilateral AOM, clinical failurerates by day 10 to 12 in children withunilateral AOM were 9% in thosetreated with amoxicillin-clavulanateversus 41% in those treated withplacebo (RD, 32%; NNT = 3) and 23%vs 60% (RD, 37%; NNT = 3) in thosewith bilateral AOM. Most common ad-verse events were diarrhea (25% vs15% in the treatment versus placebogroups, respectively; P = .05) and di-aper dermatitis (51% vs 35% in thetreatment versus placebo groups,respectively; P = .008). One placeborecipient developed mastoiditis. Ac-cording to these results, antimicrobialtreatment of AOM was more benecialthan in previous studies that usedless stringent diagnostic criteria.

Thtinen et al32 conducted a random-ized, double-blind, placebo-controlled,intention-to-treat study of amoxicillin-clavulanate (40 mg/kg/day) versusplacebo. Three hundred nineteenpatients from 6 to 35 months of agewere studied: 161 in the antibioticgroup and 158 in the placebo group.AOM denition was the presence ofMEE, distinct erythema over a bulgingor yellow TM, and acute symptomssuch as ear pain, fever, or respiratorysymptoms. Compliance was measuredby using daily patient diaries andnumber of capsules remaining at theend of the study. Primary outcomewas time to treatment failure de-ned as a composite of 6 indepen-dent components: no improvement inoverall condition by day 3, worseningof the childs condition at any time, noimprovement in otoscopic signs byday 8, perforation of the TM,



development of severe infection (eg,pneumonia, mastoiditis), and any otherreason for stopping the study drug/placebo.

Groups were comparable on multipleparameters. In the treatment group,135 of 161 patients (84%) were youn-ger than 24 months, and in the placebogroup, 124 of 158 patients (78%) wereyounger than 24 months. Treatmentfailure occurred in 18.6% of thetreatment group and 44.9% in theplacebo group (NNT = 3.8, P < .001).Rescue treatment was needed in 6.8%of the treatment group and 33.5% ofplacebo patients (P < .001). Contra-lateral AOM developed in 8.2% and18.6% of treatment and placebogroups, respectively (P = .007). Therewas no signicant difference in use ofanalgesic or antipyretic medicine,which was used in 84.2% of theamoxicillin-clavulanate group and85.9% of the placebo group.

Parents of child care attendees onplacebo missed more days of work(P = .005). Clinical failure ratesin children with unilateral AOMwere 17.2% in those treated withamoxicillin-clavulanate versus 42.7%in those treated with placebo; for bi-lateral AOM, clinical failure rateswere 21.7% for those treated withamoxicillin-clavulanate versus 46.3%in the placebo group. Reported ratesof treatment failure by day 8 were17.2% in the amoxicillin-clavulanategroup versus 42.7% in the placebogroup in children with unilateral AOMand 21.7% vs 46.3% among those withbilateral disease.

Adverse events, primarily diarrheaand/or rash, occurred in 52.8% of thetreatment group and 36.1% of theplacebo group (P = .003). Overallcondition as evaluated by the parentsand otoscopic appearance of the TMshowed a benet of antibiotics overplacebo at the end of treatment visit(P < .001). Two placebo recipients

developed a severe infection; 1 de-veloped pneumococcal bacteremia, and1 developed radiographically conrmedpneumonia.

Most studies have excluded childrenwith severe illness and all excludethose with bacterial disease otherthan AOM (pneumonia, mastoiditis,meningitis, streptococcal pharyngitis).Kaleida et al91 compared myringotomyalone with myringotomy plus anti-biotics. Severe AOM was dened astemperature >39C (102.2F) or thepresence of severe otalgia. Patientswith severe AOM in the group thatreceived only myringotomy (withoutinitial antibiotics) had much worseoutcomes.

Initial Antibiotic Therapy

The rationale for antibiotic therapy inchildren with AOM is based on a highprevalence of bacteria in the accom-panying MEE.93 Bacterial and viralcultures of middle ear uid collectedby tympanocentesis from childrenwith AOM showed 55% with bacteriaonly and 15% with bacteria and viru-ses. A benecial effect of antibioticson AOM was rst demonstrated in1968,94 followed by additional ran-domized trials and a meta-analysis95

showing a 14% increase in absoluterates of clinical improvement. Sys-tematic reviews of the literature pub-lished before 201121,59,62 revealedincreases of clinical improvementwith initial antibiotics of 6% to 12%.

Randomized clinical trials usingstringent diagnostic criteria for AOM inyoung children31,32 show differences inclinical improvement of 26% to 35%favoring initial antibiotic treatment ascompared with placebo. Greater ben-et of immediate antibiotic therapywas observed for bilateral AOM62,96 orAOM associated with otorrhea.62 Inmost randomized trials,30,75,77,88,89 an-tibiotic therapy also decreased theduration of pain, analgesic use, or

school absence and parent daysmissed from work.

Children younger than 2 years withAOM may take longer to improveclinically than older children,57 andalthough they are more likely to ben-et from antibiotics,31,32 AOM in manychildren will resolve without anti-biotics.62 A clinically signicant benetof immediate antibiotic therapy isobserved for bilateral AOM,62,96 Strep-tococcus pneumoniae infection, orAOM associated with otorrhea.62

Initial Observation for AOM

In systematic reviews of studies thatcompare antibiotic therapy for AOMwith placebo, a consistent nding hasbeen the overall favorable naturalhistory in control groups (NNT = 816).12,59,62,95 However, randomized tri-als in these reviews had varyingdiagnostic criteria that would havepermitted inclusion of some childrenwith OME, viral upper respiratoryinfections, or myringitis, therebylimiting the ability to apply thesendings to children with a highlycertain AOM diagnosis. In more re-cent AOM studies31,32 using stringentdiagnostic criteria, approximatelyhalf of young children (younger than23 years) experienced clinical suc-cess when given placebo, but theeffect of antibiotic therapy was sub-stantially greater than suggested bystudies without precise diagnosis(NNT = 34).

Observation as initial management forAOM in properly selected childrendoes not increase suppurative com-plications, provided that follow-up isensured and a rescue antibiotic isgiven for persistent or worseningsymptoms.17 In contrast, withholdingof antibiotics in all children withAOM, regardless of clinical course,would risk a return to the suppu-rative complications observed in the


preantibiotic era. At the populationlevel, antibiotics halve the risk ofmastoiditis after AOM, but the highNNT of approximately 4800 patients toprevent 1 case of mastoiditis pre-cludes a strategy of universal antibiotictherapy as a means to prevent mas-toiditis.83

The favorable natural history of AOMmakes it difcult to demonstrate sig-nicant differences in efcacy betweenantibiotic and placebo when a suc-cessful outcome is dened by relief orimprovement of presenting signs andsymptoms. In contrast, when otoscopicimprovement (resolution of TM bulg-ing, intense erythema, or both) is alsorequired for a positive outcome,31,32

the NNT is 3 to 4, compared with 8 to16 for symptom improvement alone inolder studies that used less precisediagnostic criteria. MEE, however, maypersist for weeks or months after anAOM episode and is not a criterion forotoscopic failure.

National guidelines for initial obser-vation of AOM in select children wererst implemented in the Netherlands97

and subsequently in Sweden,98 Scot-land,99 the United States,1 the UnitedKingdom,100 and Italy.101 All includedobservation as an initial treatmentoption under specied circumstances.

In numerous studies, only approximatelyone-third of children initially observedreceived a rescue antibiotic for persis-tent or worsening AOM,30,32,76,81,89,102

suggesting that antibiotic use couldpotentially be reduced by 65% in eligiblechildren. Given the high incidence ofAOM, this reduction could help sub-stantially in curtailing antibiotic-relatedadverse events.

McCormick et al30 reported on 233patients randomly assigned to receiveimmediate antibiotics (amoxicillin, 90mg/kg/day) or to undergo watchfulwaiting. Criteria for inclusion weresymptoms of ear infection, otoscopicevidence of AOM, and nonsevere AOM

based on a 3-item symptom score(OM-3) and TM appearance based onan 8-item scale (OS-8). Primary out-comes were parent satisfaction withAOM care, resolution of AOM symptomsafter initial treatment, AOM failure andrecurrence, and nasopharyngeal car-riage of S pneumoniae strains resistantto antibiotics after treatment. The studywas confounded by including patientswho had received antibiotics in theprevious 30 days.

In the watchful waiting group, 66% ofchildren completed the study withoutantibiotics. There was no difference inparent satisfaction scores at day 12.A 5-item symptom score (ETG-5) wasassessed at days 0 to 10 by usingpatient diaries. Subjects receivingimmediate antibiotics resolved theirsymptoms faster than did subjectswho underwent watchful waiting (P =.004). For children younger than 2years, the difference was greater (P =.008). Otoscopic and tympanogramscores were also lower in the antibi-otic group as opposed to the watchfulwaiting group (P = .02 for otoscopicscore, P = .004 for tympanogram).Combining all ages, failure and re-currence rates were lower for theantibiotic group (5%) than for thewatchful waiting group (21%) at 12days. By day 30, there was no differ-ence in failure or recurrence for theantibiotic and watchful waiting groups(23% and 24%, respectively). The as-sociation between clinical outcomeand intervention group was not signi-cantly different between age groups.Immediate antibiotics resulted in erad-ication of S pneumoniae carriage in themajority of children, but S pneumoniaestrains cultured from children in theantibiotic group at day 12 were morelikely to be multidrug resistant thanwere strains cultured from children inthe watchful waiting group.

The decision not to give initial antibi-otic treatment and observe should be

a joint decision of the clinician and theparents. In such cases, a system forclose follow-up and a means of be-ginning antibiotics must be in place ifsymptoms worsen or no improvementis seen in 48 to 72 hours.

Initial observation of AOM should bepart of a larger management strategythat includes analgesics, parent in-formation, and provisions for a rescueantibiotic. Education of parents shouldinclude an explanation about the self-limited nature of most episodes ofAOM, especially in children 2 years andolder; the importance of pain man-agement early in the course; and thepotential adverse effects of antibiotics.Such an approach can substantiallyreduce prescription ll rates for res-cue antibiotics.103

A critical component of any strategyinvolving initial observation for AOM isthe ability to provide a rescue antibi-otic if needed. This is often done byusing a safety net or a wait-and-seeprescription,76,102 in which theparent/caregiver is given an antibioticprescription during the clinical en-counter but is instructed to ll theprescription only if the child fails toimprove within 2 to 3 days or ifsymptoms worsen at any time. An al-ternative approach is not to providea written prescription but to instructthe parent/caregiver to call or returnif the child fails to improve within 2 to3 days or if symptoms worsen.

In one of the rst major studies of ob-servation with a safety-net antibioticprescription (SNAP), Siegel et al102 en-rolled 194 patients with protocol de-ned AOM, of whom 175 completed thestudy. Eligible patients were givena SNAP with instructions to ll theprescription only if symptoms wors-ened or did not improve in 48 hours.The SNAP was valid for 5 days. Painmedicine was recommended to betaken as needed. A phone interview wasconducted 5 to 10 days after diagnosis.



One hundred twenty of 175 families didnot ll the prescription. Reasons forlling the prescription (more than 1reason per patient was acceptable)were as follows: continued pain, 23%;continued fever, 11%; sleep disruption,6%; missed days of work, 3%; misseddays of child care, 3%; and no reasongiven, 5%. One 16-month-old boy com-pleted observation successfully but 6weeks later developed AOM in the op-posite ear, was treated with antibiotics,and developed postauricular cellulitis.

In a similar study of a wait-and-seeprescription (WASP) in the emer-gency department, Spiro et al76 ran-domly assigned 283 patients to eithera WASP or standard prescription.Clinicians were educated on the 2004AAP diagnostic criteria and initialtreatment options for AOM; however,diagnosis was made at the discretionof the clinician. Patients were ex-cluded if they did not qualify for ob-servation per the 2004 guidelines. Theprimary outcome was whether theprescription was lled within 3 daysof diagnosis. Prescriptions were notlled for 62% and 13% of the WASPand standard prescription patients,respectively (P < .001). Reasons forlling the prescription in the WASPgroup were fever (60%), ear pain(34%), or fussy behavior (6%). No se-rious adverse events were reported.

Strategies to observe children with AOMwho are likely to improve on their ownwithout initial antibiotic therapyreduces common adverse effects ofantibiotics, such as diarrhea and di-aper dermatitis. In 2 trials, antibiotictherapy signicantly increased the ab-solute rates of diarrhea by 10% to 20%and of diaper rash or dermatitis by 6%to 16%.31,32 Reduced antibiotic use mayalso reduce the prevalence of resis-tant bacterial pathogens. Multidrug-resistant S pneumoniae continues tobe a signicant concern for AOM,despite universal immunization of

children in the United States withheptavalent pneumococcal conjugatevaccine.104,105 In contrast, countrieswith low antibiotic use for AOM havea low prevalence of resistant naso-pharyngeal pathogens in children.106

Key Action Statement 4A

Clinicians should prescribe amoxi-cillin for AOM when a decision

to treat with antibiotics has beenmade and the child has not re-

ceived amoxicillin in the past 30

days or the child does not have

concurrent purulent conjunctivitis

or the child is not allergic to

penicillin. (Evidence Quality:

Grade B, Rec. Strength: Recom-

mendation)


Clinicians should prescribe an an-tibiotic with additional -lactamasecoverage for AOM when a decisionto treat with antibiotics has beenmade and the child has received

amoxicillin in the past 30 days orhas concurrent purulent conjunc-tivitis or has a history of recurrentAOM unresponsive to amoxicillin.(Evidence Quality: Grade C, Rec.Strength: Recommendation)


Clinicians should reassess the pa-tient if the caregiver reports thatthe childs symptoms have wors-ened or failed to respond to the

initial antibiotic treatment within48 to 72 hours and determinewhether a change in therapy isneeded. (Evidence Quality: Grade B,Rec. Strength: Recommendation)


Benets Effective antibiotic for most children with AOM. Inexpensive, safe,acceptable taste, narrow antimicrobial spectrum.

Risks, harms, cost Ineffective against -lactamaseproducing organisms. Adverseeffects of amoxicillin.

Benets-harms assessment Preponderance of benet.Value judgments Better to use a drug that has reasonable cost, has an acceptable

taste, and has a narrow antibacterial spectrum.Intentional vagueness The clinician must determine whether the patient is truly

penicillin allergic.Role of patient preferences Should be considered if previous bad experience with

amoxicillin.Exclusions Patients with known penicillin allergy.Strength Recommendation.

Key Action Statement Prole: KAS 4BAggregate evidence quality Grade C

Benets Successful treatment of -lactamaseproducing organisms.Risks, harms, cost Cost of antibiotic. Increased adverse effects.Benets-harms assessment Preponderance of benet.Value judgments Efcacy is more important than taste.Intentional vagueness None.Role of patient preferences Concern regarding side effects and taste.Exclusions Patients with known penicillin allergy.Strength Recommendation



If an antibiotic will be used for treatmentof a child with AOM, whether as initialmanagement or after a period of ob-servation, the clinician must choose anantibiotic that will have a high likelihoodof being effective against the most likelyetiologic bacterial pathogens with con-siderations of cost, taste, convenience,and adverse effects. This section pro-poses rst- and second-line antibioticsthat best meet these criteria whilebalancing potential benets and harms.


Despite new data on the effect of PCV7and updated data on the in vitrosusceptibility of bacterial pathogensmost likely to cause AOM, the recom-mendations for the rst-line antibioticremains unchanged from 2004. Thecurrent guideline contains revisedrecommendations regarding penicillinallergy based on new data. The in-crease of multidrug-resistant strainsof pneumococci is noted.

Microbiology

Microorganisms detected in the mid-dle ear during AOM include pathogenicbacteria, as well as respiratory viru-ses.107110 AOM occurs most frequentlyas a consequence of viral upper re-spiratory tract infection,111113 whichleads to eustachian tube inammation/

dysfunction, negative middle ear pres-sure, and movement of secretionscontaining the upper respiratory tractinfection causative virus and patho-genic bacteria in the nasopharynx intothe middle ear cleft. By using com-prehensive and sensitive microbiologictesting, bacteria and/or viruses can bedetected in the middle ear uid in upto 96% of AOM cases (eg, 66% bacteriaand viruses together, 27% bacteriaalone, and 4% virus alone).114 Studiesusing less sensitive or less compre-hensive microbiologic assays haveyielded less positive results for bacte-ria and much less positive results forviruses.115117 The 3 most commonbacterial pathogens in AOM are Spneumoniae, nontypeable Haemophilusinuenzae, and Moraxella catarrhalis.111

Streptococcus pyogenes (group A-hemolytic streptococci) accountsfor less than 5% of AOM cases. Theproportion of AOM cases with patho-genic bacteria isolated from themiddle ear uids varies dependingon bacteriologic techniques, trans-port issues, and stringency of AOMdenition. In series of reports fromthe United States and Europe from19521981 and 19851992, the meanpercentage of cases with bacterialpathogens isolated from the middleear uids was 69% and 72%, respec-tively.118 A large series from the Uni-versity of Pittsburgh Otitis MediaStudy Group reported bacterial path-ogens in 84% of the middle ear uids

from 2807 cases of AOM.118 Studies thatapplied more stringent otoscopic cri-teria and/or use of bedside specimenplating on solid agar in addition toliquid transport media have a reportedrate of recovery of pathogenic bacteriafrom middle ear exudates rangingfrom 85% to 90%.119121 When usingappropriate stringent diagnostic crite-ria, careful specimen handling, andsensitive microbiologic techniques, thevast majority of cases of AOM will in-volve pathogenic bacteria either aloneor in concert with viral pathogens.

Among AOM bacterial pathogens,S pneumoniae was the most frequentlycultured in earlier reports. Since thedebut and routine use of PCV7 in 2000,the ordinal frequency of these 3 majormiddle ear pathogens has evolved.105

In the rst few years after PCV7 in-troduction, H inuenzae became themost frequently isolated middle earpathogen, replacing S pneumoniae.122,123

Shortly thereafter, a shift to non-PCV7serotypes of S pneumoniae was de-scribed.124 Pichichero et al104 laterreported that 44% of 212 AOM casesseen in 20032006 were caused by Hinuenzae, and 28% were caused by Spneumoniae, with a high proportion ofhighly resistant S pneumoniae. In thatstudy, a majority (77%) of cases in-volved recurrent disease or initialtreatment failure. A later report125 withdata from 2007 to 2009, 6 to 8 yearsafter the introduction of PCV7 in theUnited States, showed that PCV7 strainsof S pneumoni

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