Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial

What this Trial Is About

Researchers are comparing short-acting opioids (fentanyl/hydromorphone) with long-acting opioids (methadone) for managing pain following cleft palate surgery in infants and young children. This randomized, double-blind study focuses on postoperative pain control in patients undergoing primary cleft palate repair. The study is conducted at a single center and aims to explore pain control effectiveness and opioid usage during the perioperative period and up to 30 days after surgery. Participants are randomly assigned in a 2:1 ratio to receive either methadone, given at an initial dose of 0.2 mg/kg with potential escalation to 0.25 mg/kg, or routine care with fentanyl/hydromorphone. Surgical and anesthesia care remain unchanged except for the opioid management. The study includes a dose escalation investigation and collects exploratory data during the postoperative period. During the study, participants will be monitored for opioid use from discharge from the Postanesthesia Care Unit (PACU) through the first postoperative day and up to seven days after surgery. Pain intensity and pain trajectory are assessed regularly up to hospital discharge, which may last up to four days. The total duration of participation includes follow-up assessments for up to 30 days post-surgery to evaluate pain control and opioid consumption.

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery