NCT05244226

Pediatric Pain Optimization After Tonsillectomy

Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• 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.

Detailed description

This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

Conditions

• Obstructive Sleep Apnea
• Tonsillitis
• Pain, Procedural

Interventions

Type	Name	Description
DRUG	Fentanyl/Hydromorphone	Per routine care
DRUG	Methadone	Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2022-02-17
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study