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Background: Cleft lip is one of the most common congenital anomalies in the world. There has been recently a considerable increase in use of local methods. In this regard, opioids are the common adjuvants but their safety and efficacy have not been studied extensively in children undergoing cleft lip repair. Therefore, we aimed to investigate the efficacy of local pethidine in comparison with intravenous pethidine in patients undergoing bilateral infraorbital nerve block. Methods: In this prospective, randomized, double-blind study, 40 children undergoing cleft lip repair allocated randomly to two groups. Group 1 received infraorbital injection of Marcaine and pethidine; and group 2 received infraorbital injection of Marcaine and intravenous pethidine. Statistical analysis was performed using SPSS software. Findings: The mean pain score was 5.15 ± 1.87 and 5.85 ± 2.10 in groups 1 and 2, respectively (P = 0.21). There was no significant difference in postoperative analgesic requirements between the groups (P > 0.05). There were no major complications in both groups. Conclusion: There was no significant differences between addition of pethidine to Marcaine and intravenous injection of pethidine in terms of postoperative pain score, duration of hospitalization, and postoperative analgesic requirements. Although no major complications were found, intravenous injection of pethidine is not suggested for cleft lip repair in children.