Efficacy and safety of oral paracetamol for the management of acute postoperative pain in neonates and infants: a randomized clinical trial.

Background: Neonates and infants presenting for surgery experience not only pain but also heightened pain sensitivity due to immaturity of the nervous system, which may increase the risk of neurodevelopmental disorders. Improving awareness, assessment, and timely intervention of pediatric postoperative pain is critical. Methods: Neonates and infants aged 0-12 months who underwent abdominal and/or sacroperineal surgeries between September 2022 and July 2023 were randomly assigned to a treatment group (oral paracetamol suspension, 0.1 mL/kg [10 mg/kg] administered every 6 hours for four doses after recovery from general anesthesia) or a control group (oral sterile water, 0.1 mL/kg). The primary outcome was postoperative pain intensity. Secondary outcomes included changes in liver and kidney function indices-aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine (Cr)-measured preoperatively and 48 hours postoperatively. Results: A total of 220 neonates and infants were included. Postoperative pain scores were significantly lower in the treatment than in the control group at each time point at all assessed time points (1, 6, 12, 18, 24, 36, and 48 hours after recovery from general anesthesia, Conclusions: Repeated oral administration of paracetamol after recovery from general anesthesia effectively reduces postoperative pain in neonates and infants without adversely affecting hepatic or renal function. This approach is safe and suitable for routine clinical use. Trial registration number: NCT05564819.