Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy A Randomized Double Blind Clinical Trial

What this Trial Is About

Researchers are evaluating the use of short-acting opioids (fentanyl/hydromorphone) compared to long-acting opioid methadone for managing pain after tonsillectomy surgery in children and adolescents aged 3 to 17 years. This randomized, double-blind, parallel-group study aims to find the most effective pain control method while monitoring the need for additional opioid rescue and the occurrence of side effects. The trial is sponsored by Duke University and includes multiple age cohorts to tailor dosing appropriately. Participants will be randomly assigned in a 2:1 ratio to receive either methadone or short-acting opioids during surgery. Methadone dosing starts at 0.15 mg/kg for children aged 3 to under 12 years and 0.2 mg/kg for adolescents aged 12 to 17 years, with possible dose increases based on interim safety and effectiveness reviews. Standard surgical and anesthesia care is maintained aside from the study drug administration. Two study periods cover recruitment and dose escalation phases within the age groups. During the study, researchers will collect data in the hospital and after discharge, including daily surveys for seven days and follow-up phone calls at 30 days, 3 months, and 6 months after surgery. Outcomes measured include the number of participants needing rescue opioids within six hours post-surgery and pain levels up to seven days. Safety is monitored by tracking adverse events in the recovery unit and ongoing opioid use, with the total participation period lasting up to six months.

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia