NCT06576830

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

Detailed description

This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.

Conditions

• Pain, Postoperative
• Tonsillar Hypertrophy
• Tonsillitis
• Pediatric Sleep Apnea
• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DRUG	Methadone	Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
DRUG	Fentanyl/Hydromorphone	Per routine care, given as needed

Timeline

• Start date: 2024-11-21
• Primary completion: 2028-12-31
• Completion: 2029-06-01
• First posted: 2024-08-29
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study