Intravenous Melatonin to Prevent Postoperative Agitation and Delirium in Children Aged 1 to 6 Years Undergoing Elective Surgery

What this Trial Is About

Researchers are studying children aged 1 to 6 years undergoing elective surgeries lasting at least 30 minutes under general anesthesia with sevoflurane. The trial aims to evaluate whether intravenous melatonin given during surgery can prevent postoperative agitation and emergence delirium, which are common behavioral disturbances in children waking from anesthesia. Participants are randomly assigned to receive either a single intravenous dose of melatonin at 0.15 mgkg approximately 30 minutes before the end of surgery or an equivalent volume of saline as a placebo. The study is double-blind, meaning neither participants nor researchers know which treatment is given. During and after surgery, researchers will monitor children for agitation up to about 4 hours in the recovery room, track opioid use, and check for any non-serious side effects up to 24 hours. The study will assess the safety and effects of melatonin compared to placebo to better understand its potential role in preventing these postoperative behaviors.

MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children