OBJECTIVES: 1) To compare the Mogen and Gomco clamps with regard to pain experienced during neonatal circumcision, and 2) to assess neonatal circumcision pain with and without dorsal penile nerve block (DPNB). DESIGN/ METHODS: A randomized, controlled, nonblinded clinical trial; 48 healthy, full-term infants were randomized into one of the following four groups: Gomco vs Mogen with (+) or without (-) DPNB. DPNB+ infants were injected with 0.8 mL of 1% lidocaine before circumcision. DPNB- infants received no placebo injection. Heart rate, respiratory rate, and oxygen saturation (SaO2) during the procedure were monitored and data transferred to computer files by using the Datalab software system. Crying was recorded on videotape. Pre- and postcircumcision saliva samples for cortisol analysis were collected. Heart rate, respiratory rate, SaO2, cortisol changes, and duration of crying were evaluated statistically with two-way analyses of variance and t tests. RESULTS: The type of clamp but not the use of anesthesia was significantly associated with the length of the procedure (mean Mogen time, 81 seconds; mean Gomco time, 209 seconds) and percentage of respiratory rate change. The use of anesthesia but not the type of clamp was significantly associated with percentage of crying time and percentage of SaO2 change during the procedure. Heart rate changes and total crying time were significantly associated with both the type of clamp and the use of anesthesia. Neither clamp type nor anesthesia status was significantly associated with salivary cortisol changes, although the mean increase for the DPNB- group was approximately twice that for the DPNB+ group. Fifty-six percent of infants circumcised with the Mogen clamp and DPNB did not cry at all during the procedure. CONCLUSIONS:DPNB is effective in reducing neonatal circumcision pain with either the Mogen or the Gomco clamp. For a given anesthesia condition, the Mogen clamp is associated with a less painful procedure than the Gomco. The Mogen clamp with DPNB causes the least discomfort during neonatal circumcision.
RCT Entities:
OBJECTIVES: 1) To compare the Mogen and Gomco clamps with regard to pain experienced during neonatal circumcision, and 2) to assess neonatal circumcision pain with and without dorsal penile nerve block (DPNB). DESIGN/ METHODS: A randomized, controlled, nonblinded clinical trial; 48 healthy, full-term infants were randomized into one of the following four groups: Gomco vs Mogen with (+) or without (-) DPNB. DPNB+ infants were injected with 0.8 mL of 1% lidocaine before circumcision. DPNB- infants received no placebo injection. Heart rate, respiratory rate, and oxygen saturation (SaO2) during the procedure were monitored and data transferred to computer files by using the Datalab software system. Crying was recorded on videotape. Pre- and postcircumcision saliva samples for cortisol analysis were collected. Heart rate, respiratory rate, SaO2, cortisol changes, and duration of crying were evaluated statistically with two-way analyses of variance and t tests. RESULTS: The type of clamp but not the use of anesthesia was significantly associated with the length of the procedure (mean Mogen time, 81 seconds; mean Gomco time, 209 seconds) and percentage of respiratory rate change. The use of anesthesia but not the type of clamp was significantly associated with percentage of crying time and percentage of SaO2 change during the procedure. Heart rate changes and total crying time were significantly associated with both the type of clamp and the use of anesthesia. Neither clamp type nor anesthesia status was significantly associated with salivary cortisol changes, although the mean increase for the DPNB- group was approximately twice that for the DPNB+ group. Fifty-six percent of infants circumcised with the Mogen clamp and DPNB did not cry at all during the procedure. CONCLUSIONS:DPNB is effective in reducing neonatal circumcision pain with either the Mogen or the Gomco clamp. For a given anesthesia condition, the Mogen clamp is associated with a less painful procedure than the Gomco. The Mogen clamp with DPNB causes the least discomfort during neonatal circumcision.