Background: Circumcision is a painful surgical procedure performed in neonates routinely without the benefits of analgesia. The objectives of this study were to determine the efficacy and safety of the topical anesthetic cream EMLA, for the management of neonatal circumcision pain.

Methods: Randomized double-blind placebo-controlled trial conducted on the post-natal ward of an urban teaching hospital. Healthy full-term male neonates circumcised in the first 5 days of life were eligible to participate. One gram of EMLA or placebo cream was applied on the penis under an occlusive dressing for 60-80 minutes prior to circumcision. Behavioral and physiologic responses were recorded throughout the procedure. One follow-up (1 to 18 hours after the dose) blood sample was obtained from each infant to measure methemoglobin (% of hemoglobin), lidocaine, and prilocaine concentrations.

Results: 68 infants were included in the safety analysis and 59 in the efficacy analysis. Mean gestational age and birthweight did not differ between treatment groups. Infants treated with EMLA had lower facial activity scores (F[1,55]=6.98, p=0.01),% cry duration (F[1,55]=18.14, p<0.001), and heart rate (F[1,35]=8.09, p=0.007) during the circumcision compared to infants treated with placebo. Mean% methemoglobin concentrations did not differ (1.3% in both groups). Low concentrations (<0.2mcg/mL) of lidocaine and prilocaine were detected in 23 (61%) and 21 (55%) of EMLA-treated infants, respectively.

Conclusion: EMLA is efficacious and safe for the management of neonatal circumcision pain and may be used for this procedure. Future research should investigate the efficacy of combined interventions.Funded by Astra Pharma Inc., Canada, and a grant from the Medical Research Council of Canada - Pharmaceutical Manufacturers Association of Canada.