Comparison of bilateral infraorbital nerve block versus intravenous ketorolac for cleft lip repair in children: a randomised controlled trial

Abstract

Introduction: Cleft lip repair in children is associated with significant postoperative pain, which, if inadequately managed, may lead to complications such as wound dehiscence and delayed recovery. Bilateral infraorbital nerve block (BIONB) with 0.25% bupivacaine has emerged as a potential alternative to intravenous ketorolac for postoperative analgesia. This randomized trial compares the analgesic efficacy and safety of BIONB with intravenous ketorolac in paediatric cleft lip repair.

Methods: This randomized, prospective, double-blind study included 74 children aged 12–60 months undergoing elective cleft lip repair under general anaesthesia at a tertiary hospital in Nigeria. Participants were randomized into two groups: Group BO (BIONB with 1 mL of 0.25% bupivacaine per side) and Group KO (0.5 mg/kg intravenous ketorolac). The primary outcome was postoperative pain, assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Secondary outcomes included analgesic duration, rescue analgesic consumption, and complications. Data were analysed using independent sample t-tests, with p < 0.05 considered statistically significant.

Results: A total of 74 children were randomized, with 34 patients in each group contributing data to the primary outcome. BIONB demonstrated significantly lower mean CHEOPS scores in the immediate postoperative period (0-hour: 4.12 ± 0.5 vs. 8.61 ± 0.6, p=0.03). Analgesic duration was significantly longer in Group BO (8 hours) compared to Group KO (6 hours, p=0.03). Total rescue analgesic consumption over 24 hours was significantly lower in Group BO (223.08 ± 214.12 mg vs. 657.83 ± 248.49 mg, p=0.02). No complications were reported in either group.

Conclusions: Bilateral infraorbital nerve block with 0.25% bupivacaine is a safe and effective analgesic technique for cleft lip repair in children, providing superior pain control, prolonged analgesia, and reduced postoperative analgesic requirements compared to intravenous ketorolac. This technique should be considered as a valuable addition to postoperative pain management protocols in paediatric surgical patients.