NCT06962306

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Not 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 cleft palate surgery in infants and young children.

Detailed description

This is a single center, randomized, double blind, parallel-group dose escalation investigation in infants and children undergoing cleft palate surgery which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as perioperative analgesics. Surgical and anesthesia care, except for 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

• Cleft Palate
• Pain
• Postoperative Care
• Perioperative Care
• Children

Interventions

Type	Name	Description
DRUG	Methadone hydrochloride	Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
DRUG	Fentanyl/Hydromorphone	Per routine care

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-06-04
• Completion: 2027-07-04
• First posted: 2025-05-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study