OBJECTIVE: Recognizing the concerns about the use of local anesthesia in neonatal circumcision, a painful procedure usually performed without analgesia or anesthesia, we undertook a study of acetaminophen for pain management of this procedure. DESIGN: A prospective, randomized, double-blind, placebo-controlled, clinical trial of acetaminophen analgesia in 44 healthy full-term neonates undergoing circumcision was conducted. Beginning 2 hours before Gomco circumcision, neonates received either acetaminophen (15 mg/kg per dose, 0.15 mL/kg per dose) or placebo (0.15 mL/kg per dose) every 6 hours for 24 hours. Neonates were monitored intraoperatively for changes in heart rate, respiratory rate, and crying time. Postoperative pain was assessed at 30, 60, 90, 120, 360 minutes, and 24 hours using a standardized postoperative comfort scoring system. Feeding behavior was also assessed before and after circumcision by nursing observation. RESULTS: Neonates in both groups showed significant increases in heart rate, respiratory rate, and crying during circumcision with no clinically significant differences observed between the groups. Postoperative comfort scores showed no significant differences between the groups until the 360-minute postoperative assessment, at which time the acetaminophen group had significantly improved scores (P < .05). Feeding behavior deteriorated in breast- and bottle-fed neonates in both groups, and acetaminophen did not seem to influence this deterioration. CONCLUSIONS: This study confirms that circumcision of the newborn causes severe and persistent pain. Acetaminophen was not found to ameliorate either the intraoperative or the immediate postoperative pain of circumcision, although it seems that it may provide some benefit after the immediate postoperative period.
RCT Entities:
OBJECTIVE: Recognizing the concerns about the use of local anesthesia in neonatal circumcision, a painful procedure usually performed without analgesia or anesthesia, we undertook a study of acetaminophen for pain management of this procedure. DESIGN: A prospective, randomized, double-blind, placebo-controlled, clinical trial of acetaminophenanalgesia in 44 healthy full-term neonates undergoing circumcision was conducted. Beginning 2 hours before Gomco circumcision, neonates received either acetaminophen (15 mg/kg per dose, 0.15 mL/kg per dose) or placebo (0.15 mL/kg per dose) every 6 hours for 24 hours. Neonates were monitored intraoperatively for changes in heart rate, respiratory rate, and crying time. Postoperative pain was assessed at 30, 60, 90, 120, 360 minutes, and 24 hours using a standardized postoperative comfort scoring system. Feeding behavior was also assessed before and after circumcision by nursing observation. RESULTS: Neonates in both groups showed significant increases in heart rate, respiratory rate, and crying during circumcision with no clinically significant differences observed between the groups. Postoperative comfort scores showed no significant differences between the groups until the 360-minute postoperative assessment, at which time the acetaminophen group had significantly improved scores (P < .05). Feeding behavior deteriorated in breast- and bottle-fed neonates in both groups, and acetaminophen did not seem to influence this deterioration. CONCLUSIONS: This study confirms that circumcision of the newborn causes severe and persistent pain. Acetaminophen was not found to ameliorate either the intraoperative or the immediate postoperative pain of circumcision, although it seems that it may provide some benefit after the immediate postoperative period.