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: