What this Trial Is About

Postoperative agitation and emergence delirium are common early negative behavioral reactions in children waking from anesthesia, including symptoms like crying, thrashing, and confusion. These symptoms affect about 25% of children. Previous studies have suggested that oral melatonin may help reduce the risk of these symptoms, with some showing a dose-response effect. This trial aims to study the safety and preventive effects of intravenous melatonin given during surgery to reduce postoperative agitation and emergence delirium in children aged 1 to 6 years undergoing elective surgery. Participants will be randomly assigned to receive either intravenous melatonin or a placebo (isotonic sodium chloride solution) during their surgery under general anesthesia with sevoflurane. The melatonin used is 1 mg/mL for injection. The study is designed as a double-blind, placebo-controlled trial to fairly evaluate the effects of melatonin compared to placebo. Children will be monitored for signs of emergence agitation for up to approximately 4 hours after surgery, which corresponds to their stay in the Post-Anesthetic Care Unit (PACU). Researchers will assess the incidence of agitation during this period. Safety will also be evaluated, considering that previous studies found no serious adverse effects with melatonin use in children. Participation involves a single surgical and recovery period with close observation during and after anesthesia.

MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children