All male infants under the age of 2.5 months with normal penile anatomy were eligible for the study. By design, we excluded the infants with abnormal penile anatomy (e.g., hypospadias), those whose parents did not apply topical EMLA cream as instructed or when parents did not keep the scheduled follow-up appointment. The circumcision was performed by a board certified neonatologist and a board certified anesthesiologist in an office setting equipped with all necessary resuscitation equipment. Parents were instructed to apply approximately 2.5 grams of EMLA cream on the shaft of the penis and 1 cm around its base one hour prior to the appointed time for circumcision. In order to avoid absorption of the EMLA cream into the disposable diaper, parents were instructed to apply a 20 × 20 cm piece of household plastic wrap on the inside of the disposable diaper over the penis. Upon arrival to the office, the infants received 25–30 mg/kg acetaminophen, either orally or per-rectum, as preemptive analgesia (Acamoli syrup 120 mg/ml or Acamoli suppository 150 mg, Teva Medical, Petah Tikva, Israel). Oral doses of 40/kg body weight of acetaminophen have been used for post-operative pain treatment in infants [9]. Since acetaminophen has a large volume of distribution, a relatively large initial dose is required irrespective of whether treatment is administered orally or rectally. Tréluyer et al. found that the optimum oral dose was 30 mg/kg [10]. From 0.3–0.5 ml 30% sucrose-solution was given orally just prior to the analgesic injection [11]. All study infants received an injection of lidocaine 1% 6–8 mg as a subcutaneous ring block to the base of the penis by means of a hypodermic 27 G beveled needle (Becton Dickinson, Drogheda, Ireland) [12]. The infants were then injected with either lidocaine 1% (Ezracaine 1%, Rafa Laboratories, Jerusalem, Israel) 4–5 mg/kg (the lidocaine group which was comprised of infants who underwent the circumcision before May 18, 2003) or bupivacaine 1.5–2 mg/kg (Marcaine, Astra, Sweden), (the bupivacaine group consisting of infants who were circumcised after May 18, 2003) in a DPNB using a 25 G needle (Becton Dickinson) [13]. In order to avoid inadvertent intravenous injection, suction was applied to the syringe handle prior to injection, ensuring that the tip of the needle was not inside a blood vessel.
Circumcision was performed 4–5 minutes after analgesia administration. An additional dose of 0.3–0.5 ml 30% sucrose solution was dripped orally. The infants lay on a padded surface and circumcision was performed using the Mogen circumcision clamp (all procedures were carried out by S.D.) [14]. The infants were observed for adverse effects of analgesia or circumcision for at least 15 minutes and underwent a physical examination.
The parents were given an instruction sheet and verbally instructed by the physician to administer a dose of 30 mg/kg liquid acetaminophen 4 hours after the procedure if they subjectively felt that the infant displayed any signs they perceive as pain. One repeat dose was also recommended 4 hours after that if symptoms of pain or discomfort reappeared. The parents were instructed to contact the physician if pain persisted thereafter. A follow-up appointment was scheduled within 2–5 days after the circumcision, and the number of acetaminophen doses administered to the infants during the 24-hour period after the circumcision was routinely recorded. Consent was obtained from both parents.
Statistical methods included the t-test, Chi-square test, and regression analysis. Data are presented as mean ± SD. A P value of
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