Dexamethasone for Acute Asthma Exacerbations inChildren: A Meta-analysis

abstractBACKGROUND AND OBJECTIVE: Dexamethasone has been proposed asan equivalent therapy to prednisone/prednisolone for acute asthmaexacerbations in pediatric patients. Although multiple small trialsexist, clear consensus data are lacking. This systematic review andmeta-analysis aimed to determine whether intramuscular or oraldexamethasone is equivalent or superior to a 5-day course of oralprednisone or prednisolone. The primary outcome of interest wasreturn visits or hospital readmissions.

METHODS: A search of PubMed (Medline) through October 19, 2013, byusing the keywords dexamethasone or decadron and asthma or statusasthmaticus identified potential studies. Six randomized controlled trialsin the emergency department of children #18 years of age comparingdexamethasone with prednisone/prednisolone for the treatment ofacute asthma exacerbations were included. Data were abstracted by4 authors and verified by a second author. Two reviewers evaluatedstudy quality independently and interrater agreement was assessed.

RESULTS: There was no difference in relative risk (RR) of relapse be-tween the 2 groups at any time point (5 days RR 0.90, 95% confidenceinterval [CI] 0.46–1.78, Q = 1.86, df = 3, I2 = 0.0%, 10–14 days RR 1.14,95% CI 0.77–1.67, Q = 0.84, df = 2, I2 = 0.0%, or 30 days RR 1.20, 95% CI0.03–56.93). Patients who received dexamethasone were less likely toexperience vomiting in either the emergency department (RR 0.29,95% CI 0.12–0.69, Q = 3.78, df = 3, I2 = 20.7%) or at home (RR 0.32, 95%CI 0.14–0.74, Q = 2.09, df = 2, I2 = 4.2%).

CONCLUSIONS: Practitioners should consider single or 2-dose regi-mens of dexamethasone as a viable alternative to a 5-day course ofprednisone/prednisolone. Pediatrics 2014;133:493–499

AUTHORS: Grant E. Keeney, MD,a Matthew P. Gray, MD,a

Andrea K. Morrison, MD, MS,a Michael N. Levas, MD,a

Elizabeth A. Kessler, MD, MS,a Garick D. Hill, MD, MS,a MarcH. Gorelick, MD, MSCE,a Jeffrey L. Jackson, MD, MPHb,c

Departments of aPediatrics, and bGeneral Internal Medicine,Medical College of Wisconsin, Milwaukee, Wisconsin; andcZablocki VAMC, Milwaukee, Wisconsin

KEY WORDSdexamethasone, prednisone, prednisolone, asthma, statusasthmaticus

ABBREVIATIONSCI—confidence intervalED—emergency departmentIM—intramuscularPO—per osRR—relative risk

Dr Gorelick conceptualized the study; Drs Gray, Keeney,Morrison, Levas, Kessler and Hill conceptualized and designedthe study, designed the data collection instruments, coordinatedand supervised data collection, and drafted the initialmanuscript; Dr Jackson participated in study design, carriedout the initial analyses, and reviewed and revised themanuscript; and all authors approved the final manuscript assubmitted.

www.pediatrics.org/cgi/doi/10.1542/peds.2013-2273

doi:10.1542/peds.2013-2273

Accepted for publication Dec 4, 2013

Address correspondence to Grant E. Keeney, MD, Department ofPediatrics, Medical College of Wisconsin, 999 North 92nd St,Milwaukee, WI 53226. E-mail: gkeeney@mcw.edu

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2014 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they haveno financial relationships relevant to this article to disclose.

FUNDING: Supported by the National Center for AdvancingTranslational Sciences, National Institutes of Health, throughgrant 8UL1TR000055. Its contents are solely the responsibility ofthe authors and do not necessarily represent the official viewsof the National Institutes of Health. Funded by the NationalInstitutes of Health (NIH).

POTENTIAL CONFLICT OF INTEREST: The authors have indicatedthey have no potential conflicts of interest to disclose.

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Asthma affects .6 million children inthe United States, making it the mostcommon chronic disease of childhood.1,2

As such, asthma accounts for 2% ofall ambulatory care and emergencydepartment (ED) visits by patients,18years of age.3 Asthma is a chronic in-flammatory disease characterized byairway edema, bronchoconstrictionand airway hyperresponsiveness. Inaddition to bronchodilators, cortico-steroids are the cornerstone of therapyfor acute asthma exacerbations. Theysystemically reduce inflammation, de-crease mucus production, and enhancethe effects of b-agonists.2 National andinternational guidelines advise earlyadministration of systemic cortico-steroids for moderate or severe exac-erbations and for mild exacerbationsthat do not immediately and completelyrespond to short-acting b-agonists.1,4

Current treatment regimens consist oforal prednisone or prednisolone takenonceor twicedaily for5days.Oral (PO)orintramuscular (IM) dexamethasone hasbeen proposed as an equivalent therapy.Potential advantages include a longerhalf-life requiring a shorter course, in-creased compliance with a single dose,and less vomiting with dexamethasone.Althoughmultiplesmall trialsexist, clearconsensus data are lacking.

OBJECTIVE

Thepurpose of this systematic reviewandmeta-analysis of randomized clinicaltrials is to determine whether PO or IMdexamethasone is equivalent or superiorto a 5-day course of oral prednisone orprednisolone. The primary outcome ofinterest was unscheduled return visits(clinic visit, ED visit, orhospital admission)foracuteasthmaexacerbation inpediatricpatients. Secondary outcomes includedvomiting in the ED and vomiting at home.

METHODS

Trials were identified using PubMed (Med-line)withsearchtermsof“dexamethasone”

OR “decadron” AND “asthma” OR “sta-tus asthmaticus” in all search fields,including only human trials withoutlanguage restriction. The final searchwas conducted on October 19, 2013.

Studies were included in the meta-analysis if they were a randomized con-trolled trial of treatment of acute asthmaexacerbation in either an ambulatory orED setting comparing dexamethasonewith prednisone or prednisolone inchildren #18 years of age. Patientshospitalized during the initial study en-counter were not included in the analy-sis of return visits. Articles wereexcluded at the title and abstract phaseby 2 authors (M.L. and G.H.). Referencelists from review articles and thosestudies included in the meta-analysiswere reviewed by hand without identifi-cation of additional articles meetingcriteria.

Data were abstracted by 4 authors (G.K.,M.P.G., A.M., M.L.) and all data were ver-ifiedby a secondauthor. Abstracted dataincluded subject characteristics (age inmonths, gender, ethnicity), asthma se-verity score, treatment characteristics(number of albuterol treatments in theED), adverse effects (vomiting), andclinical outcomes (hospitalization dur-ing initial ED visit, asthma score at EDdischarge, subjective improvement, andrelapse rate as defined by an un-scheduled visit to a clinic, ED, or a hos-pitalization). Outcomes were extractedas either dichotomous or continuousvariables based on study report.

Study quality of the included trials wasassessed using the Cochrane risk ofbias tool, the 6-question instrumentcreated and validated by Jadad andcolleagues, and 2 additional items de-scribing the presence of industrysponsorship in the trial and whetherintent to treat analysis was performed.5,6

Two reviewers (G.H. and E.K.) evaluatedstudy quality independently.

Data were pooled using a fixed-effectsmodel. Relapse rates were reported

at different time intervals and combinedformeta-analysisonlywhensimilar timeintervals were reported (5 days, 10–14days, and 30 days). Differences betweengroups were tested using randomeffects meta-regression.7 Heterogeneitywas assessed using the I2 method.8 Weassessed for small study effects (pub-lication bias) using the methods ofPeters et al9 for dichotomous outcomesand Egger et al10 for continuous out-comes. We examined the potential forundue influence of any given study bylooking at the percentage of total weightto the final pooled results for each studyand by examining meta-influence plots.Potential sources of heterogeneity wereexplored by using stratified analysis. Allanalyseswere performed by using Stataversion 12.1 (Stata Corp, College StationTX). This studywas supported by a grantfrom the National Center for AdvancingTranslational Sciences, National Insti-tutes of Health.

RESULTS

Our search identified 667 articles. Ap-plication of inclusion and exclusion cri-teria resulted in 6 studies that wereincluded in our analysis (Fig 1).11–16 Allof the included studies were performedin EDs and had a mean of 171 partic-ipants (range 15–272). All studies butone (Gordon et al12) defined relapse asan unplanned clinic visit, return ED visit,or an unplanned hospital admissionrelated to their initial asthma exacerba-tion. Dexamethasone was given as a sin-gle IM dose in 3 studies,12,14,15 as a singleoral dose in 1 study,11 and as multipleoral doses in 2 studies13,16 (Table1). In-cluded studies were from the UnitedStates (n = 5) and Canada (n = 1). Allstudies were among children witha mean age of 53.2 (95% confidence in-terval [CI] 41.5–64.9) months. Partic-ipants were mostly boys (63.5%). One ofthe studies included a predominantlyHispanic population (80%).12 Among theremaining studies, participants were

494 KEENEY et al at Indonesia:AAP Sponsored on August 25, 2015pediatrics.aappublications.orgDownloaded from

34.7% white and 37.9% African Ameri-can. Study quality ranged from 3 to 8 onthe Jadad scale (Table 1) and assess-ments using the results of the Cochranerisk of bias tool are presented in Table 2.Interrateragreementwas excellent witha k of 0.90.

In comparing the group receiving dexa-methasone to prednisone, there were nodifferencesatbaseline inage(44.4vs56.7months, P= .66), proportion of boys (63.6vs 65.8, P= .37), or initial asthma severityscore (standardized mean 3.5 vs 3.1, P =.22, 4 studies). There were no differencesin the likelihood of improvement inasthma scores during the initial ED visitbetween groups (relative risk [RR] 1.01,95% CI 0.93–1.10, Q = 0.38, df = 2, I2 =0.0%), the number of albuterol treat-ments received in the ED (2.5, 95% CI1.8–3.2 vs 2.7, 95% CI 1.9–3.5, P for dif-ference = .87, 4 studies), or in post-treatment asthma severity scores (RR1.38, 95% CI 0.0–2.81 vs 1.27, 95% CI0.0–2.71,P fordifference=0.78). Therewasno difference in the average amount ofimprovement in asthma scores between

groups (standard mean difference2.56, 95% CI 2.27–2.84 vs 2.30, 95% CI2.03–2.56, P for difference = 0.56).There was no difference in rates ofhospitalization during the initial EDvisit (RR 0.91, 95% CI 0.66–1.26, Q = 1.68,df = 4, I2 = 0.0%).

In the dexamethasone group, there wasa 6.6% (95% CI 0.3% –10.0%) relapserate by 5 days, increasing to 13.8%(95% CI 11.3–16.4) by 2 weeks (Fig 2). Inthe prednisone/prednisolone groupthe 5-day relapse rate was 3.6% (95% CI1.1%–6.2%), increasing to 11.9% (95%CI 0.9%–14.4%) by 2 weeks. There wasno difference in relapse rate betweenthe 2 groups at any time point (5 daysRR 0.90, 95% CI 0.46–1.78, Q = 1.86, df =3, I2 = 0.0%, 10–14 days RR 1.14, 95% CI0.77–1.67, Q = 0.84, df = 2, I2 = 0.0%, or30 days RR 1.20, 95% CI 0.03–56.93),although the 30-day relapse rate wasreported in only 1 study.

Patients who received dexamethasonewere less likely to experience vomitingin either the ED (Fig 3, RR 0.29, 95% CI0.12–0.69, Q = 3.78, df = 3, I2 = 20.7%) or

at home (Fig 4, RR 0.32, 95% CI 0.14–0.74, Q = 2.38, df = 2, I2 = 4.2%).

The paucity of studies limited ourabilityto perform sensitivity analyses. Therewas no evidence of publication bias forany of our outcomes, including relapserates (5 days: P = .84, 14 days: P = .47),hospitalization (P = .75), improvementin asthma severity scores (P = .29),vomiting in the ED (P = .72), or vomitingat home (P = .93). There was no evi-dence of undue influence on any ofthese outcomes from any particularstudy on meta-influence plots; no studycontributed .29% of the total weightto any pooled analysis, suggesting lackof undue influence. Dexamethasone wasadministered orally in 3 studies and IMin 3 studies. However, the studiesreported outcomes at different timepoints, making subanalyses tentative.There was no difference in likelihood ofrelapse for dexamethasone comparedwith prednisone/prednisolone, regard-less of the route of dexamethasone ad-ministration (P = .43). Similarly, therewere no differences for hospitalization(P = .75), or likelihood of improvementin asthma score (P = .85). Both PO andIM dexamethasone were associatedwith less vomiting in the ED (PO 0.32,95% CI 0.11–0.91, IM 0.06, 95% CI 0.003–0.94). Route of administration accoun-ted for only a small portion (26.7%) ofthe variance in this outcome. There wasno difference in route of dexametha-sone administration for vomiting athome (P= .95) with oral dexamethasonestill resulting in less vomiting thanprednisolone (RR 0.32, 95% CI 0.13–0.77), although the benefit was lost forthe single trial of IM dexamethasone (RR0.32, 95% CI 0.01–7.7).

CONCLUSIONS

This meta-analysis examined whetherintramuscular or oral dexamethasoneis equivalent or superior to a 5-daycourse of prednisone/prednisolone foracute asthma exacerbations in pediatric

FIGURE 1Study selection.

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TABLE1

Included

Studies

Author

Interventiona

Comparisona

InclusionCriteria

ExclusionCriteria

JadadScore

SingleIM

dose

Gries,2000

14Dexamethasone

1.7mg/kg

(max

36mg)

IM3

1dose

Prednisone

orprednisolone

1mg/kg

(max

20mg)

POtwicedaily

35d

Age6mo-7y,previous

historyofasthma,

mild

tomoderateasthmaexacerbation

Useofsteroidinprevious

2wk,severe

asthmaexacerbation(requiring

hospitalization),fever

.101,or

documentedRSVinfection

3

Gordon,20071

2Dexamethasone

0.6mg/kg

(max

15mg)

IM3

1dose

Prednisolone

2mg/kg

(max

50mg)

POdaily

35d

Age18

mo-7y,previous

historyof

asthma,mild

tomoderate

asthmaexacerbation

Useofsteroidinprevious

month,allergy

tosteroid,TB

orvaricella

exposure,

previous

enrollm

ent,major

coexisting

illness,O2saturation,

88%on

room

air,pectus

excavatum,orneed

forIV

4

Klig,19971

5Dexamethasone

0.3mg/kg

(max

15mg)

IM3

1dose

Prednisone

2mg/kg

(max

100mg)

PO3

1dose

then

1mg/kg

POdaily

32d

Age3–16

y,previous

historyof

asthma,mild

tomoderate

asthmaexacerbation

Useofsteroidinprevious

month,oxygen

saturation#

95%on

room

air,

significant

recent

hospitalizationfor

asthmaor

ICUstay

inthepastyear,

7dofprednisone

inpastyear,or

major

coexistingillness

3

SingleOralDose

Altamimi,2006

11Dexamethasone

0.6m

g/kg

(max

18mg)

PO3

1dose,

placeboPO

twicedaily

35d

Prednisone

orprednisolone

1mg/kg

(max

30mg)

PO3

1dose,then

1mg/kg

POtwicedaily

35d

Age2–16

y,previous

historyof

asthmaandmild

tomoderate

asthmaexacerbation

Useofsteroidinprevious

2wk,complete

recovery

after1bronchodilator,historyof

previous

intubationor

PICU

admission,

major

coexistingillness,history

ofacute

allergicreaction,activevaricella,orHSVinfections

8

MultipleOralDoses

Greenberg,2008

13Dexamethasone

0.6mg/kg

(max

16mg)

POonce

daily

32d

Prednisone

2mg/kg

(max

80mg)

PO3

1dose,then1mg/kg

(max

30mg)

POtwicedaily

34d

Age2–18

y,previous

historyof

asthma,andacuteexacerbation

asthma

Useofsteroidinprevious

month,history

ofintubation,varicella

exposure,

possibleforeignbody

aspiration,

major

coexistingillness,significant

respiratorydistress,previousenrollm

ent,

notelephoneforfollow-up,or

$2episodes

ofem

esisaftersteroiddose

inED

4

Qureshi,2001

16Dexamethasone

0.6m

g/kg

(max

16mg)

POonce

daily

32d

Prednisone

orprednisolone

2mg/kg

(max

60mg)

PO3

1dose,then

1mg/kg

(max

60mg)

POdaily

34d

Age2–18

y,previous

historyof

asthma,acuteexacerbation,

andrequired

atleast2b-agonist

treatm

entsinED

Useofsteroidinprevious

4wk,history

ofintubation,varicella

exposure,

concurrent

stridor,concernfor

intrathoracicforeignbody,m

ajor

coexisting

illness,orneed

forimmediateairw

ayintervention

3

HSV,herpes

simplex

virus;max,m

aximum

;RSV,respiratory

syncytialvirus;TB,tuberculosis.

aFirstdose

ofmedicationprovided

intheED.

496 KEENEY et al at Indonesia:AAP Sponsored on August 25, 2015pediatrics.aappublications.orgDownloaded from

patients discharged to home from theED. Fixed effects methods increase thechance of finding differences. Finding nodifferences in a fixed effects model isa more conservative choice when com-paring2different treatmentoptions. Thepooled results failed to demonstratea statistically significant difference be-tween the 2 therapies for the primaryoutcome of relapse rate to clinic, ED, orhospitalization, suggesting that the 2therapies are equivalent.

Our decision to combine studies with dif-ferent routes and dosing of dexamethasone

was an effort to increase generalizability.A subgroup analysis failed to show sta-tistically significant differences regard-lessof thefollow-upperiods.The4studiesthat reported 5-day follow-up relapserates all used a single dose of IM or POdexamethasone.11,12,14,15 Five days was themost common follow-up duration and isthe most clinically relevant period inwhich to detect treatment failure. This issupported by the fact that 5-day coursesof oral corticosteroids have not beenshown to be superior to 3-day courses foroutpatient management of children with

acute exacerbations.17 There was no dif-ference detected in studies reporting re-currence rates at 5, 10 to 14, or 30 days’follow-up.

Significantly fewer patients receivingdexamethasone vomited in the ED or athome after discharge. This finding hasclinical significance for improving pa-tient and parental satisfaction. Thelower rate of vomiting with dexameth-asone possibly reflects a difference inpalatability that has been shown inprevious studies.18,19 However, the groupof studies that used oral dexamethasone

TABLE 2 Cochrane Risk of Bias Quality Assessment

Study Allocation SequenceAdequate

Allocation Concealed Blinding ofParticipants

Blinding ofOutcomes

Outcome Data AdequatelyAddressed

Free From SelectiveOutcome Reporting

Free From OtherProblems

Altamimi11 Yes Yes Yes Yes No Unclear YesGordon12 Yes Yes No No Yes No Yesa

Qureshi16 No No No No Yes Unclear Yesa

Greenberg13 Uncleara Uncleara Yes Unclear No Unclear YesGries14 Unclear Unclear No No Yesa Unclear YesKlig15 Unclear Unclear No No Yes Unclear Yesa Disagreement between reviewers.

FIGURE 2Relapse rates.

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was a heterogeneous group in thateach used a different preparation fortheir oral medications. Additionally,single or 2-dose regimens may increase

compliance with systemic corticoste-roid administration in acute asthmaexacerbations compared with longertreatment courses.

There are potential limitations to thisanalysis, including publication bias andstudy quality. A systematic and com-prehensive search of the published lit-erature, as well as trial registries, wasconducted to avoid bias. Two additionalunpublished studies were identified.Attempts to contact the first and cor-responding authors for all unpublishedstudy results were unsuccessful inobtaining additional data for the meta-analysis. Unpublished clinical trialsare more likely to confirm the null hy-pothesis and would support our pooledestimate for the primary outcome ofinterest. To further address possiblestudy selection bias, we used 2 in-dependent reviewers, had clear in-clusion and exclusion criteria, andexcellent interrater agreement. An ad-ditional limitation is that the paucity oftrials made it difficult to examine im-portant potential differences. For ex-ample, we were unable to address

FIGURE 3Vomiting in the ED.

FIGURE 4Vomiting at home.

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whether IM and PO dexamethasone areequally effective, whether a single oraldexamethasone dose is equivalent tomultiple doses, and whether there aredifferences in efficacy and palatabilitybetween different formulations of oral

prednisone/prednisolone. Furthermore,all our results are based on ED-basedstudies, and it is unclear whether thiswould translate to the ambulatory clinicsetting. Future research should focus onthese important questions.

Based on our findings, emergency physi-cians should consider single or 2-dosedexamethasone regimens over 5-dayprednisone/prednisolone regimensfor the treatment of acute asthmaexacerbations.

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11. Altamimi S, Robertson G, Jastaniah W, et al.Single-dose oral dexamethasone in theemergency management of children withexacerbations of mild to moderate asthma.Pediatr Emerg Care. 2006;22(12):786–793

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DOI: 10.1542/peds.2013-2273; originally published online February 10, 2014; 2014;133;493Pediatrics

A. Kessler, Garick D. Hill, Marc H. Gorelick and Jeffrey L. JacksonGrant E. Keeney, Matthew P. Gray, Andrea K. Morrison, Michael N. Levas, ElizabethDexamethasone for Acute Asthma Exacerbations in Children: A Meta-analysis

  

rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Grove Village, Illinois, 60007. Copyright © 2014 by the American Academy of Pediatrics. All and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elkpublication, it has been published continuously since 1948. PEDIATRICS is owned, published, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

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DOI: 10.1542/peds.2013-2273; originally published online February 10, 2014; 2014;133;493Pediatrics

A. Kessler, Garick D. Hill, Marc H. Gorelick and Jeffrey L. JacksonGrant E. Keeney, Matthew P. Gray, Andrea K. Morrison, Michael N. Levas, ElizabethDexamethasone for Acute Asthma Exacerbations in Children: A Meta-analysis

  

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