OBJECTIVE: To determine the efficacy of topical anesthetic cream, eutectic mixture of local anesthetics (EMLA), in alleviating pain from neonatal circumcision. DESIGN: Randomized, controlled trial. SETTING:Normal newborn nursery in a university teaching hospital. PATIENTS: Twenty-seven newborn, full-term male neonates, aged 1 to 3 days. OUTCOME MEASURES: Heart rate, transcutaneous oxygen saturation, facial activity, and crying. RESULTS: Compared with baseline, all newborns experienced pain as evidenced by increased heart rate of an average of 40 beats per minute (F [8, 25] = 14.12; P < .0001), decreased oxygen saturation of 3% (F [8, 25] = 15.02; P < .0001), and more facial actions indicative of pain (F [8, 25] = 5.25; P < .002) during all phases of the procedure. Compared with placebo, EMLA significantly attenuated the pain response as shown by lower heart rate of an average of 25 beats per minute (F [1, 25] = 14.92; P < .001), higher oxygen saturation of 5%, particularly during the clamping and lysis phases (F [1, 25] = 19.83; P < .0001), 20% less facial activity (F [1, 25] = 12.01; P < .002), and 15% less crying during the clamping, Gomco clamp application, and incision of the foreskin. There were no differences between groups in the spectral crying parameters. CONCLUSIONS: Circumcision procedure produces pain responses that EMLA diminishes. Thus, EMLA may be a useful agent for pain management in neonatal circumcision.
RCT Entities:
OBJECTIVE: To determine the efficacy of topical anesthetic cream, eutectic mixture of local anesthetics (EMLA), in alleviating pain from neonatal circumcision. DESIGN: Randomized, controlled trial. SETTING: Normal newborn nursery in a university teaching hospital. PATIENTS: Twenty-seven newborn, full-term male neonates, aged 1 to 3 days. OUTCOME MEASURES: Heart rate, transcutaneous oxygen saturation, facial activity, and crying. RESULTS: Compared with baseline, all newborns experienced pain as evidenced by increased heart rate of an average of 40 beats per minute (F [8, 25] = 14.12; P < .0001), decreased oxygen saturation of 3% (F [8, 25] = 15.02; P < .0001), and more facial actions indicative of pain (F [8, 25] = 5.25; P < .002) during all phases of the procedure. Compared with placebo, EMLA significantly attenuated the pain response as shown by lower heart rate of an average of 25 beats per minute (F [1, 25] = 14.92; P < .001), higher oxygen saturation of 5%, particularly during the clamping and lysis phases (F [1, 25] = 19.83; P < .0001), 20% less facial activity (F [1, 25] = 12.01; P < .002), and 15% less crying during the clamping, Gomco clamp application, and incision of the foreskin. There were no differences between groups in the spectral crying parameters. CONCLUSIONS: Circumcision procedure produces pain responses that EMLA diminishes. Thus, EMLA may be a useful agent for pain management in neonatal circumcision.
Authors: Maher R Khdour; Hussein Othman Hallak; Kawther Shab'an Atallah Alayasa; Qusai Nabeel AlShahed; Ahmed F Hawwa; James C McElnay Journal: Int J Clin Pharm Date: 2011-05-13