Efficacy and Safety of Lidocaine-Prilocaine Cream for Pain During Circumcision

Abstract

Background Neonatal circumcision is a painful surgical procedure often performed without analgesia. We assessed the efficacy and safety of 5 percent lidocaine–prilocaine cream (Emla) in neonates undergoing circumcision. Methods We carried out a double-blind, randomized, controlled trial in 68 full-term male neonates: 38 were assigned to receive lidocaine–prilocaine cream, and 30 to receive placebo. One gram of lidocaine–prilocaine or placebo cream was applied to the penis under an occlusive dressing for 60 to 80 minutes before circumcision. Behavioral (facial activity and time spent crying) and physiologic (heart rate and blood pressure) responses were recorded during the procedure. Blood samples were obtained at various times after drug application for measurements of methemoglobin and plasma lidocaine, prilocaine, and o -toluidine (a metabolite of prilocaine). Results A total of 68 and 59 neonates were included in the safety and efficacy analyses, respectively. Demographic characteristics such as gestat...