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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Dorsal penile nerve block vs topical placebo for circumcision in low-birth-weight neonates.
OBJECTIVE: To investigate the efficacy and safety of dorsal penile nerve block (DPNB) and eutectic mixture of lidocaine (EMLA) for palliation of pain associated with circumcision in low-birth-weight infants.
DESIGN: Randomized, blinded, controlled trial.
SETTING: Intensive care nursery (step down unit) at Georgetown University Medical Center, Washington, DC.
PARTICIPANTS: Fifty neonates with weights of 1600 to 2500 g at the time of circumcision who were discharged from the hospital between May 1994 and June 1995 were randomly assigned to the DPNB, EMLA, or control group. Twenty-five infants who were otherwise eligible were excluded because of parental refusal of consent to participate.
INTERVENTIONS: Infants in the DPNB and EMLA groups received anesthesia with subcutaneous injection of 1% lidocaine hydrochloride or topical EMLA, respectively. The control group received sham anesthesia with topical placebo (acid mantle cream).
MAIN OUTCOME MEASURES: Changes in physiologic variables (heart rate, blood pressure, oxygen saturation, and respiratory rate) and behavioral score 20 minutes before, during, and 5 and 20 minutes after circumcision between DPNB and control groups. Surgical complications and adverse effects were also monitored.
RESULTS: Fifty infants were enrolled in the study: 19 randomized to the DPNB group, 19 to the control group, and 12 to the EMLA group. Enrollment into the EMLA group was suspended early because of redness and blistering of the foreskin in 2 infants, and this entire group was excluded from further analysis. The clinical course was similar in all groups of infants. All circumcisions were performed without complication or technical difficulty. Statistically significant differences were noted in heart rate, respiratory rate, and behavioral score when comparing the DPNB group with controls during and after circumcision.
CONCLUSION: Dorsal penile nerve block is safe and effective in controlling pain associated with circumcision in low-birth-weight infants.
DESIGN: Randomized, blinded, controlled trial.
SETTING: Intensive care nursery (step down unit) at Georgetown University Medical Center, Washington, DC.
PARTICIPANTS: Fifty neonates with weights of 1600 to 2500 g at the time of circumcision who were discharged from the hospital between May 1994 and June 1995 were randomly assigned to the DPNB, EMLA, or control group. Twenty-five infants who were otherwise eligible were excluded because of parental refusal of consent to participate.
INTERVENTIONS: Infants in the DPNB and EMLA groups received anesthesia with subcutaneous injection of 1% lidocaine hydrochloride or topical EMLA, respectively. The control group received sham anesthesia with topical placebo (acid mantle cream).
MAIN OUTCOME MEASURES: Changes in physiologic variables (heart rate, blood pressure, oxygen saturation, and respiratory rate) and behavioral score 20 minutes before, during, and 5 and 20 minutes after circumcision between DPNB and control groups. Surgical complications and adverse effects were also monitored.
RESULTS: Fifty infants were enrolled in the study: 19 randomized to the DPNB group, 19 to the control group, and 12 to the EMLA group. Enrollment into the EMLA group was suspended early because of redness and blistering of the foreskin in 2 infants, and this entire group was excluded from further analysis. The clinical course was similar in all groups of infants. All circumcisions were performed without complication or technical difficulty. Statistically significant differences were noted in heart rate, respiratory rate, and behavioral score when comparing the DPNB group with controls during and after circumcision.
CONCLUSION: Dorsal penile nerve block is safe and effective in controlling pain associated with circumcision in low-birth-weight infants.
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