Intraurethral Lidocaine for UrethralCatheterization in Children:A Randomized Controlled TrialNaveen Poonai, MSc, MDa,b, Jennifer Li, MDa, Cindy Langford, RNa, Natasha Lepore, BMSca, Anna Taddio, PhDc,Sandra Gerges, PharmDc, Larry Stitt, PhDd, John Teefy, BSca, Karim Manji, BMSca, Matt Castelo, BSca, Michael Rieder, MD, PhDa,Tingting Qui, MDa, Doreen Matsui, MDa, Samina Ali, MDe,f

abstractOBJECTIVES: To determine whether lidocaine is superior to nonanesthetic lubricant (NAL) forrelieving pain in children undergoing urethral catheterization (UC).

METHODS: Children 0 to 24 months requiring UC were randomized to NAL or topical andintraurethral 2% lidocaine gel. Primary outcome was facial grimacing in the pre to during drugadministration and catheterization phases. Secondary outcome was caregiver satisfaction byusing a Visual Analog Scale.

RESULTS: There were 133 participants (n = 68 lidocaine, n = 65 NAL). There were no significantdifferences in mean (SD) scores during UC between lidocaine and NAL (86.4% [121.5%] vs 85.2%[126.6%]), respectively (D [confidence interval (CI)] = 21.2 [221.0 to 49.0], P = .4). There wasa significantly greater difference in mean (SD) scores during instillation of lidocaine versus NAL(61.8% [105.6%] vs 3.2% [84.9%]), respectively (D [CI] –58.6 [–95.0 to –32.0], P , .001). Therewere no significant differences in mean (SD) parental satisfaction scores between lidocaine and NAL(4.8 [3.2] vs 5.9 [2.9]), respectively (CI–0.1 to 2.2; P = .06). In the subgroup analysis, age, gender, andpositive urine culture did not significantly influence between-group differences in facial grimacing.

CONCLUSIONS: Compared with NAL, topical and intraurethral lidocaine is not associated withsignificant pain reduction during UC, but significantly greater pain during instillation.Therefore, clinicians may consider using noninvasive pain-reducing strategies for youngchildren who require UC.

WHAT’S KNOWN ON THIS SUBJECT: Urethralcatheterization is a painful, yet commonprocedure to obtain a sterile urine sample inyoung children. There are conflicting resultsregarding the effectiveness of lidocaine toreduce pain, and it is unclear if it should beroutinely used.

WHAT THIS STUDY ADDS: In young children,combined topical and intraurethral lidocainedoes not reduce pain during urethralcatheterization and is associated with more painthan nonanesthetic lubricant during instillation.Clinicians should use noninvasive methods ofanalgesia during this painful procedure.

aDepartment of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, Ontario,Canada; bChildren’s Health Research Institute, and dLawson Health Research Institute, London Health SciencesCentre, London, Ontario, Canada; cLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada;eDepartment of Pediatrics, University of Alberta, Edmonton, Alberta, Canada; and fWomen and Children’s HealthResearch Institute, Edmonton, Alberta, Canada

Dr Poonai conceptualized and designed the trial, monitored data collection, and drafted the initialmanuscript; Drs Rieder, Matsui, and Ali aided in the conceptualization of the trial, interpretation ofthe results, and critically reviewed and revised the manuscript; Dr Li assisted in designing the trial,coordinated and supervised data collection, and revised the manuscript; Ms Lepore, Mr Teefy,Ms Langford, and Dr Qui assisted in the design of the study, performed data collection, assisted ininterpretation of the results and creation of the data analysis plan, and revised the manuscript;Dr Stitt designed the statistical plan, analyzed the data, and revised the manuscript; Drs Taddio andGerges assisted in the design of the trial, designed the data collection tool, conducted data analysis(pain assessments), and revised the manuscript; Mr Castelo and Mr Manji assisted in the trial’sdesign, coded and aided in interpretation of the data, ensured data integrity, and revised themanuscript; and all authors approved the final manuscript as submitted.

This trial has been registered at www.clinicaltrials.gov (identifier: NCT01690767).

www.pediatrics.org/cgi/doi/10.1542/peds.2015-1852

DOI: 10.1542/peds.2015-1852

Accepted for publication Jul 29, 2015

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Suspected urinary tract infections(UTI) account for up to 14% ofpediatric emergency department(ED) visits yearly.1 Among febrileinfants, the prevalence of UTI isas high as 7% and definitiveconfirmation requires either urethralcatheterization (UC) or suprapubicaspiration.2–4 As such, UC is one ofthe most frequently performed EDprocedures.5,6

There is ample evidence thatanalgesia is underused in the EDsetting.7–10 Furthermore, untreatedpain in childhood has been reportedto lead to slower healing11–14 andlong-term issues, such as anxiety,needle phobia,15 hyperesthesia,13 andfear of medical care.16 Despitegeneral acceptance that childrenexperience significant pain-relatedurethral procedures,17–19 suboptimalanalgesia is particularly prevalent inchildren undergoing UC, withanalgesic rates ranging from 0%6

to 2%.20 A more recent surveyfound that 44% of EDs did notoffer any analgesia for UC inchildren.9 This wide range suggestsa great deal of uncertainty regardingthe best analgesic options forchildren undergoing UC. Thisuncertainty may be explained bythe conflicting results of pediatrictrials of topical analgesia. Theseinconsistencies could be due tosuboptimal application times,restraining the infant, small samplesizes,21,22 or exclusively topicaladministration.23

The importance of providing optimalpain treatment is echoed by both theWorld Health Organization24 and theAmerican Academy of Pediatrics,25

who recently reaffirmed its advocacyfor adequate analgesia for painfulprocedures in children. Our objectivewas to determine if a combination oftopical and intraurethral lidocainewith a longer application timerelieved the pain of UC in unrestrainedchildren aged 0 to 24 months withouta concomitant increase in instillation-associated pain.

METHODS

Study Design and Setting

We conducted a randomized, blinded,placebo-controlled, superiority trialdesigned to test the hypothesis thata combination of intraurethral andtopical 2% lidocaine gel was superiorto nonanesthetic lubricant (NAL), thestandard of care, in reducing painassociated with UC. Participants wererecruited between April 2012 andOctober 2014 from the pediatric EDof the Children’s Hospital, LondonHealth Sciences Centre. The studywas approved by WesternUniversity’s Health Sciences ResearchEthics Board and the interventionprotocol received approval fromHealth Canada. The study wasregistered on www.clinicaltrials.gov(NCT01690767).

Participants

We included children 0 to 24 monthswho presented to the ED andrequired a UC to obtain a urinesample. We excluded children withknown hypersensitivity to lidocaine,previous UC, or analgesia within 24hours of study enrollment, externalgenitourinary anomalies, andprevious participation in the study.

A trained research assistant assessedeligibility, obtained informed consent,and enrolled and performed allcorrespondence with participants.Participants were screenedconsecutively for eligibility for 10hours per week between 1200 and1700 hours when both the researchnurse and research assistant wereavailable. Written informed consentwas obtained from caregivers.

Blinding

Parties blinded to the interventionincluded the nurse performing UC,outcome assessors, and caregiverswho agreed to leave the room duringthe intervention phase.

Interventions

Randomization and allocationconcealment were

pharmacy-controlled using computer-based randomization (www.randomization.com). Eligibleparticipants were randomized ina 1:1 allocation, with a block size of6 to 2% lidocaine gel (Lidocainehydrochloride; AstraZeneca, Toronto,Canada) or a water-based NAL(Lubricating jelly; Health Care Plus,Toronto, Canada). Concealment ofallocation was performed usingsequentially numbered, opaque,sealed envelopes. The interventionswere kept in their original packagingat room temperature. A volumeof 1 mL of 2% lidocaine gel wasapplied topically to the externalmeatus using sterile gauze for5 minutes before intraurethral 2%lidocaine administration. The latterwas delivered by a trained researchnurse by using a 3-mL plastic syringeattached to a 25-gauge angiocatheterand inserted 5 mm into the distalurethra. As previously described,22

children ,7 kg and $7 kg received1 mL and 1.5 mL of intraurethrallidocaine, respectively. Five minuteswere allowed to elapse from thetime of intraurethral lidocaineadministration to UC. In the NALgroup, the participant’s diaper wasremoved during the time segmentcorresponding to topical lidocaineadministration. During the timesegment corresponding tointraurethral lidocaineadministration, participants in theNAL group received a topicalapplication of 1 mL NAL to theexternal meatus for 5 minutes byusing sterile gauze (Fig 1). Topicaland intraurethral interventions andUC were performed using aseptictechnique. The child was placed in thelithotomy position with the legsabducted just enough to clean theperineum and visualize the urethralmeatus. Apart from the interventionphase and UC, the child was allowedto assume either a supine or lateraldecubitus position to preventdisplacement of the intervention.Participants did not receive anyanalgesic agents (cointerventions)

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before or during any of the studyphases.

A trained research assistantvideotaped the infant’s face andthoroughly reviewed the nursingrecord for adverse events associatedwith the procedure. Urine cultureresults were followed for 5 dayspostcatheterization. Video segmentscommenced 30 seconds beforeintervention administration andended 30 seconds after UC. For thepurposes of analysis, the videos weresegmented into 4 phases: pre andduring lidocaine/NAL application;pre and during UC. Each 30-secondvideo segment was assigneda randomization number. Caregiverswho agreed to leave the room duringthe intervention phase and returnduring the catheterization phasewere asked to rate their level of

satisfaction with their child’s comfortduring UC.

Outcome Measures

The primary outcome was the pre-during difference in pain associatedwith both instillation and UC. Thiswas assessed by the percentage oftime children displayed facialgrimacing, specifically brow bulging(BB), nasolabial furrowing (NLF), andeye squeeze (ES), during the first30 seconds of each phase of theprocedure. We used facial grimacingas the primary outcome because ithas been described as “the mostreliably specific indicator of pain” ininfants26 and it permitted theoutcome assessor to remain blindedbecause only the participant’s faceneeded to be recorded. The 3 facialindicators included in the assessment

of pain were derived from theNeonatal Facial Coding System(NFCS), a 10-item behavioral painscale validated in preterm,27 full-term,28 and older infants29 withexcellent construct validity26,30 andhigh interobserver reliability at thebedside.26,31 The rating of all 10items of the NFCS is very laborintensive. To reduce complexity, wemeasured the 3 most common facialactions (BB, ES, NLF), similar to thatreported in other studies.27,32–37

These 3 actions have been found to bemost frequently associated withtissue damage and exhibit highinterobserver reliability,26 internalconsistency, contribute most heavilyto the pain experience,32,33 and areassociated with improved specificitywithout compromising sensitivity orvalidity.35

Using a previously describedapproach,37 the presence or absenceof a facial action was scored for2-second intervals for each videosegment by 2 independent outcomeassessors blinded to study hypothesisand group assignment. Thepercentage of time the facial actionwas present was calculated for each30-second segment by dividing thesum of the number of times the facialaction was observed in each 2-secondinterval by the total number ofintervals observed, and multiplyingby 100. Comparisons were made onthe pre-during difference scorebetween groups37 for the sum ofscores for all 3 indicators (ie, BB, ES,NLF). The score ranged from 0% to300%. To maintain blinding ofoutcome assessors, only participants’faces were recorded. To minimizeorder bias, video segments were sentto 2 independent outcome assessorsas individual digital files identified bya unique identification numbergenerated by a computerized randomnumber generator (https://www.random.org/sequences). Outcomeassessors were trained by an expertin the NFCS (AT). Exploratoryoutcomes included an a priorisubgroup analysis of the primary

FIGURE 1Study protocol for each group and corresponding video segment recorded.

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outcome based on age (,180 or$180 days), gender, and positiveurine culture as covariates.

Secondary outcomes includedcaregiver satisfaction with theirchild’s comfort during UC usinga 100-mm Visual Analog Scale andfrequency of adverse events includingthe possibility of introducinga pathogenic organism into the urine.The latter was defined as thepresence of at least 50 000 coloniesper mL of a single uropathogenicorganism.4

Statistical Analysis

The intention-to-treat population wasdefined as all participants whounderwent UC and in whom videosegments were of sufficient qualityfor analysis. Means and SDs orfrequencies and percentages, asappropriate, were used to summarizebaseline characteristics. To facilitatemaking inferences at a participantrather than a time segment level, theprimary outcome was assessed usingan arcsine (square root)transformation of an analysis ofcovariance. A prespecified subgroupanalysis by gender, age, and UTI onthe pre-during difference betweengroups during UC was performed byusing a test of interaction betweenthe subgroup factor and thetreatment group. Differences inparental satisfaction were comparedby using the Student’s t test andfrequencies of adverse outcomesbetween groups were comparedusing the Pearson x2. Interrateragreement between outcomeassessors was determined by usingan intraclass correlation. Weconsidered a between-groupdifference of 20% in facial grimacingscores to be a minimal clinicallyimportant difference.37 Assuming anSD of 35%, 65 participants per groupwere required to detect a 20%between-group difference at the 5%2-sided level of significance with 90%power.38 Data were analyzed by usingthe SPSS statistical software package(version 21; IBM SPSS Statistics, IBM

Corporation, Chicago, IL). P , .05 wasconsidered statistically significant.

RESULTS

Participants

Flow of participants through the trialcan be found in Fig 2. Of 157randomized participants, 133 wereincluded in the analysis (68 in thelidocaine group and 65 in the NALgroup). Demographic features ofparticipants are summarized inTable 1. All participants who wereincluded in the analysis weresuccessfully catheterized on the firstattempt.

Primary Outcome

There was significantly greater painassociated with instillation ofintraurethral lidocaine comparedwith NAL as measured by facialgrimacing (Table 2). However, therewere no significant differences in painassociated with UC amongparticipants who received lidocaineversus NAL (Table 3). In the

subgroup analysis, tests of interactionwere nonsignificant for theinstillation phase (group 3 age, P =.13; group 3 gender, P = .76; group 3positive urine culture, P = .77), andUC (group 3 age, P = .72; group 3gender, P = .89; group 3 positiveurine culture, P = .39). Given baselineheterogeneity in weight, andtherefore dose of lidocaine, betweengroups, a post hoc analysis wasperformed to explore whetherbetween-group differences in painwere associated with weight (,7 vs$7 kg). The test of interaction wasnonsignificant for both the instillationphase (P = .22) and UC (P = .87).The interrater agreement betweenoutcome assessors for all variableswas 0.89 (95% confidence interval[CI] 0.88 to 0.90).

Secondary Outcomes

There were no significant differencesin mean (SD) parental satisfactionscores between lidocaine (n = 64) andNAL (n = 57) groups (4.8 [3.2] versus5.9 [2.9]), respectively (95% CI –0.1

FIGURE 2Flow of participants through the trial. MD, medical doctor.

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to 2.2; P = .06). There were nosignificant differences in theproportion of positive urine culturesbetween participants in the lidocaine(15/65) and NAL (11/68) groups(P = .3). There were 3 cases ofa falsely positive urine culture inthe NAL group and 1 case in thelidocaine group. There were noadverse events (hypersensitivity,bacteremia, sepsis, gross urethralinjury, cardiovascular or respiratorydecompensation, or death) observed.

DISCUSSION

In this randomized controlled trial ofunrestrained children 0 to 24 months,we demonstrated that topical andintraurethral lidocaine gel was noteffective in reducing the pain ofUC. Our findings suggest thatintraurethral lidocaine should not beroutinely recommended for UC inyoung children, as its instillation isassociated with significantly greaterpain than NAL.

It is widely held that UC is painful forboth children17–19,22,23 and adults.39

The suggested practice to reduceUC-related discomfort in childrenhas typically included instillation ofan anesthetic gel.40 Althoughevidence supporting the use oflidocaine gel in adults is clear,41

pediatric studies have yieldedconflicting results.

Our finding that lidocaine did notsignificantly alleviate distressassociated with UC contradictsevidence of the efficacy of lidocaine inolder children. In children aged 4 to11 years, Gerard et al21 found that 3,2-minute instillations of topical andintraurethral lidocaine gel wereassociated with significantly less pain.Similarly, adult studies have foundlidocaine to be effective in reducingpain associated with UC.41,42

Studies in younger children, however,are consistent with our findings.Mularoni et al22 found no significantdifferences on a global measure ofdistress in children aged 2 to 24months undergoing UC. The authorsconcluded that the administrationtime of 2 minutes might not havebeen sufficient for optimal analgesia.In addition, restraining patients in thelithotomy position may havecontributed to distress.22 Vaughanet al23 studied the effectiveness ofa 2-minute application of lidocaineto the urethral meatus in children,2 months of age and found nosignificant benefit. The authors statedthat the short application time andexclusively topical administrationmay have mitigated optimalanalgesia, particularly in boys.23

Age-related differences in responseto painful procedures are welldescribed.43,44 It has been postulatedthat older children are better able to

differentiate “pain” from “fear,”45 andmay be more capable of appearingstoic.46 We restricted ourinvestigation to children ,2 years ofage to ensure our results could beextrapolated to the demographicmost likely to receive a UC for sterileurine collection.3,4 The mean age ofparticipants in the lidocaine groupwas ∼3 months greater than the NALgroup and calls into question whetherthis could have affected the finalresults. The fact that the subgroupanalysis showed that age was notassociated with responses in facialgrimacing between groups suggeststhat this was not the case.Alternatively, developmentaldifferences underlying the responseto painful stimuli may not have beendistinct enough between the agegroupings we prespecified (eg, ,180days and $180 days).

Our study sought to overcomelimitations of previous workdemonstrating lidocaine to beineffective for UC. We used anapplication time of 5 minutes becausetopical lidocaine requires anadministration time of at least4 minutes for effective analgesia.47,48

We also chose not to restrain theparticipants in the lithotomy position.Although restraint has been used inprevious protocols,22,23 it wasdescribed as distressing.22 We feltthat by allowing the child to moveand be comforted after the instillationphase, it would reduce overall anxietyduring UC and enhance thegeneralizability of our findings.Previous authors also have reportedthat intraurethral instillation oflidocaine is distressing to infants.22,23

In an effort to minimize pain, weapplied lidocaine to the externalmeatus for 5 minutes beforeintraurethral instillation. The fact thatthese strategies did not alleviate painsuggests several possibilities. First,the instillation phase may havecaused some tissue damage or mayhave been emotionally distressing,thereby sensitizing the child to UC.Second, the child’s pain experience

TABLE 2 Facial Grimacing Pre-During Difference Between Groups During the Instillation Phase

Facial Grimacing Parameter Lidocaine, n = 68 NAL, n = 65 D (95% CI) P

Total 61.8 (105.6) 3.2 (84.9) 258.6 (–95.0 to –32.0) ,.001BB 21.5 (37.1) 0.2 (34) 221.3 (–33.6 to –9.2) ,.001ES 19.4 (33.5) 0.6 (26.1) 218.8 (–29 to –8.4) ,.001NLF 21 (37.9) 2.4 (29.5) 218.6 (–30.2 to –6.9) ,.001

Data are presented as mean (SD). Facial grimacing scores represent the number of 2-second time segments in which theaction was seen divided by the total number of 2-second time segments multiplied by 100.

TABLE 1 Demographic Features of Participants

Lidocaine, n = 68 NAL, n = 65

Age, d 234.5 (196.1) 141.2 (144.1)No. of boys (%) 30 (44) 37 (57)Weight, kg 8 (3.1) 6.3 (2.2)No. with previous urethral catheterization (%) 17 (25) 18 (28)

Data are presented as mean (SD) unless otherwise noted.

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may have included an anxietycomponent fueled by parentalseparation, cold exposure, andother factors that could not belessened with an anesthetic.Although we cannot be sure thathandling to facilitate the instillationof lidocaine rather than theinstallation itself was not the sourceof distress, participants in bothgroups received a similar degree ofhandling.

Despite contradictory evidence forbenefit in children,21–23 clinicians uselidocaine to alleviate pain associatedwith UC.9,21 Our findings provideevidence that intraurethral lidocaineis ineffective at alleviating pain inyoung children undergoing UC.Societal recommendations2–4 havemade UC one of the most commonlyperformed procedures to obtaina sterile urine specimen in youngchildren. However, it is also one of themost painful.17–19 Therefore, it isimperative that future studies explorethe effectiveness of noninvasivestrategies, such as sucrose,distraction, and positioning, whichhave been found to be effective inother painful procedures.49–51 Untilfuture studies can explore the utilityof these strategies, we believe thatnoninvasive approaches to reduce

pain should be used in childrenundergoing UC.

The main limitation of our study wasthe lack of blinding of the researchassistant filming the video segments.Our study design favored thepragmatic end of the Pragmatic-Explanatory Continuum IndicatorSummary.52 As such, our decision notto restrain participants made itdifficult to obscure the lower half ofthe participant’s body and thereforeblind the research assistant. However,given that no video segments weredeemed uninterpretable, we believethe possibility of bias introduced bythe research assistant was minimal.We were also not able to blind theresearch nurse performing theinstillation, as the use of anintraurethral placebo was deemedunethical. However, we attempted tominimize bias by blinding theoutcome assessors. In addition, theresearch nurse performing UC wasnot involved in collecting data orassessing outcomes. Anotherlimitation was our decision not tomeasure physiologic parameters.However, evidence suggests that ininfants, facial grimacing is morespecific to tissue damage during aninvasive procedure than is heartrate.26 Finally, UC was performed by

nursing staff with varied clinicalexperience. Although there isa possibility that this may haveintroduced variability, all nurses inour department are trained to usea standardized protocol for UC.Inclusion of multiple operatorsimproves generalizability of thefindings.

CONCLUSIONS

UC is a commonly performed butpainful procedure, particularly inyoung children. We have shown thatdespite a 5-minute application timewithout a restraint, the combinationof topical and intraurethral lidocaineis not associated with significant painreduction during UC and is associatedwith significantly more pain duringinstillation. Our results suggest thatintraurethral lidocaine should not beadministered to young childrenundergoing UC. Future work shouldexplore the effectiveness ofnoninvasive analgesic strategies foryoung children who require thiscommon, painful procedure.

ABBREVIATIONS

BB: brow bulgingCI: confidence intervalED: emergency departmentES: eye squeezeNAL: nonanesthetic lubricantNFCS: neonatal faces coding

systemNLF: nasolabial furrowingUC: urethral catheterizationUTI: urinary tract infection

Address correspondence to Naveen Poonai MSc MD FRCPC, Paediatric Emergency Department, Children’s Hospital, London Health Sciences Centre, London, Ontario,

Schulich School of Medicine and Dentistry, London, Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9. E-mail: naveen.poonai@lhsc.on.ca

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

Copyright © 2015 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: Dr Taddio holds research grant funding from Pfizer and receives study supplies from Ferndale and Natus. The other authors have indicated

they have no financial relationships relevant to this article to disclose.

FUNDING: Supported by a Department of Paediatrics Resident Research Grant, Western University, London, Ontario, Canada.

POTENTIAL CONFLICT OF INTEREST: Dr Taddio holds research grant funding from Pfizer and receives study supplies from Ferndale and Natus. The other authors have

indicated they have no potential conflicts of interest to disclose.

TABLE 3 Facial Grimacing Pre-During Difference Between Groups During Catheterization Phase

Facial Grimacing Parameter Lidocaine, n = 68 NAL, n = 65 D (95% CI) P

Total 86.4 (121.5) 85.2 (126.6) 21.2 (–21.0 to 49.0) .4BB 27.6 (40.7) 26 (42.7) 21.6 (–15.9 to 12.7) .6ES 29.2 (41.7) 30.8 (42.6) 1.6 (–12.9 to 16.1) .4NLF 29.5 (42.1) 28.3 (46.7) 21.2 (–16.4 to 14.1) .5

Data are presented as mean (SD). Facial grimacing scores represent the number of 2-second time segments in which theaction was seen divided by the total number of 2-second time segments multiplied by 100.

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DOI: 10.1542/peds.2015-1852 originally published online September 28, 2015; 2015;136;e879Pediatrics 

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Randomized Controlled TrialIntraurethral Lidocaine for Urethral Catheterization in Children: A

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Randomized Controlled TrialIntraurethral Lidocaine for Urethral Catheterization in Children: A

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ISSN: . 60007. Copyright © 2015 by the American Academy of Pediatrics. All rights reserved. Print American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,has been published continuously since . Pediatrics is owned, published, and trademarked by the Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it

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