STUDY DESIGN: This was a randomized placebo-controlled blinded clinical trial.
POPULATION: We included 71 patients who were recruited from the inpatient nursery of a military community hospital over a 5-month period.
OUTCOME MEASURE: The primary outcome was the percentage of the procedure time neonates spent crying. Secondary outcomes were the percentage change in heart rate from baseline, the percentage of oxygen saturation, and the score from the modified behavioral pain scale.
RESULTS: There were no significant differences between the oral glucose and water groups among any of the pain-related measurements. The DPNB group had significantly lower pain-related measurements (P <.05).
CONCLUSIONS: Concentrated glucose administered orally does not provide significant analgesia for neonatal circumcision. The use of DPNB significantly reduced objective measurements of pain and physiologic stress in infants undergoing circumcision.
Neonatal circumcision is one of the most common surgical procedures performed in the United States.1,2 Neonates clearly perceive pain during this procedure;3 however, many physicians still do not offer analgesia or anesthesia. The pain of neonatal circumcision has measurable physiologic consequences (eg, pulse oximetry).4 Also, this early painful experience may have sustained effects on the neonate some detectable months into the future.5-9
Previous studies have demonstrated dorsal penile nerve block (DPNB), subcutaneous ring block, and some topical anesthetic formulations (eg, eutectic mixture of local anesthetics cream) to be effective.10-16 The barriers to offering analgesia or anesthesia are related to a variety of factors, such as new skill acquisition, fear of complications, or inconvenience of technique.17-19 The circumcision policy statement issued by the American Academy of Pediatrics in 1999 acknowledged that analgesia was safe and effective and that adequate pain relief should be provided.20
Other investigators have linked the use of concentrated sugar solutions with decreased pain activity in neonates undergoing mildly painful procedures, including circumcision. The administration of glucose for pain relief is thought to be because of the induction of endorphin production. Two mL of 12%, 25%, and 50% sugar solutions before heel stick blood collection caused a 50% decrease in the total crying time for infants, compared with those who received only sterile water.21,22 The improved pain tolerance is blocked by the administration of naloxone.21-23 However, none of this work has directly compared the use of an oral sugar solution with an established analgesic or anesthetic technique. We directly compared the analgesic properties of sterile water (placebo), concentrated oral glucose (50% dextrose solution [D50]), and DPNB.
We undertook a randomized double-blind placebo-controlled clinical trial to test the hypothesis that 2 mL of D50 would reduce the total crying time during the circumcision by 50%. One group received placebo (sterile water); a second group was given D50; and the third group received a DPNB. A power analysis with an a of 0.05 and a b of 0.80 revealed that 16 patients in each of the 3 arms would be adequate to detect a 50% difference in the percentage of the procedure time the infant was crying. After approval by the Human Subjects Review Committee, a total of 71 patients were enrolled from November 1, 1996, through March 13, 1997.
Subjects were chosen from all male live births at Naval Hospital Bremerton during the study period. Exclusion criteria included any high-risk characteristics as determined by the medical staff. Of 232 male children born during the study interval, 162 underwent circumcision, and 71 were included in our study after obtaining informed consent for the procedure and participation in the study. Fifty parents refused participation. Forty-one neonates were not included because of the unavailability of the investigators.
The primary outcome for this study was the percentage of the procedure time the infant spent crying. Secondary outcomes are the percentage change in heart rate from baseline, the percentage of oxygen saturation, and the modified behavioral pain scale (MBPS) score at 30-second intervals Table 1.
The infants were randomized (by computer modeling) to 1 of the 3 arms of the study: 24 received 2 mL of sterile water orally; 24 underwent DPNB; and 23 received 2 mL of D50 orally. The DPNB was carried out in the usual manner. The base of the penis in all patients was covered with a sterile 2 × 2 gauze pad secured with tape to obscure evidence of a DPNB. All circumcisions were performed using a Gomco clamp (Allied Healthcare Products, Inc; St. Louis, Mo) and begun between 2 and 6 minutes of the pain relief intervention.