Combination Analgesia for Neonatal Circumcision: A Randomized Clinical Trial of EMLA alone versus addition of Sucrose, Dorsal Penile Nerve Block (DPNB), and Ring Block
Rana Sharara-Chami, MD, Zavi Lakissian, MD, Lama Charafeddine, MD, Nadine Milad, MD, Yaser El-Hout, MD.
American University of Beirut Medical Center, Beirut, Lebanon.
BACKGROUND: Neonatal circumcision is one of the most frequently performed procedures, yet there is no consensus on what constitutes the most effective pain management. We sought to compare different analgesia modalities. METHODS: This is a double-blinded randomized clinical trial to compare three combination analgesics (EMLA + Sucrose; EMLA + Sucrose + Ring Block; EMLA + Sucrose + DPNB) to the traditional topical analgesic (EMLA) used alone during circumcision on term healthy newborn males. The procedure was performed in the normal nursery following parental consent. The newborn was leg-restrained in supine position on a circumcision board and attached to a monitor. All circumcisions were performed by the same pediatric urologist using the GOMCO Technique. The newborns were videotaped (face & torso) during the procedure, excluding the surgeon and the field. The neonatal infant pain scale (NIPS) ranging from 0 (mild to no pain) to 6 (>4 severe pain) was used by nurses every hour for 4 hours to assess post-operative pain. The same scale was used by 2 blinded pediatricians who independently reviewed the videos to assess the pain experienced during each stage of circumcision. The circumcision procedure was divided into six color-coded stages, which were called out by the urologist to avoid biasing the evaluators of the perceived pain of each stage. RESULTS: A total of 70 newborns were enrolled . They were block-randomized into 3 intervention groups and the control based on a 2:1 ratio. The average duration of the procedure was 6 minutes (σ ± 1). Reliability tests were performed on the NIPS (Cronbach's α .930). To assess inter-rater reliability, measure of agreement kappa (κ) was calculated (.843). Multivariate analysis, ANOVA and Dunnett's post-hoc tests were performed based on the assumption of homogeneity of co-variance. No statistically significant results were found between analgesia and post-operative pain (NIPS 0-1). During circumcision, NIP scores ranged from 2 to 6, and all intervention groups were highly significantly different (p .000) from the control (EMLA). The scores for each of the 6 stages of circumcision were compared; the most painful stage was lysis of adhesion between the foreskin and the glans (NIPS 4.8 σ ± 1.56). Each stage was then compared based on randomization group; all results were similarly significant, except during the third and most painful stage, where EMLA + Sucrose proved marginally insignificant compared to EMLA alone (p .06). During fourth stage (application of GOMCO), between-group-comparisons found EMLA + Sucrose + Ring block (p .002; .009) to show statistically significant variation form EMLA + Sucrose + DPNB and EMLA + Sucrose; respectively. Vital signs remained in normal range: Heart rate 146 (σ ± 17); Oxygen saturation 96% (σ ± 3); Respiratory rate 45 (σ ± 4); and continuous crying time during procedure 30 seconds (σ ± 15). CONCLUSIONS: Combination analgesics provide better pain management during circumcision than EMLA alone. Sucrose provided adjunct pain relief, however not adequately during the most painful stage of the procedure. DPNB and Ring have proven more effective, with a marginal advantage of Ring over DPNB.
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