Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Phase 4

Not yet recruiting

• Conditions: Cleft Palate; Pain; Postoperative Care; Perioperative Care; Children
• Interventions: Drug: Methadone hydrochloride; Drug: Fentanyl/Hydromorphone

• Registration Number: NCT06962306
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Study Start: 2025-05-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 6 months to 4 years of age
• Primary cleft palate repair
• Signed informed consent by parent or legal guardian

Exclusion Criteria

• History of chronic kidney or liver disease
• Planned admission to the Pediatric Intensive Care Unit (PICU)
• Additional procedures under general anesthesia for which opioids would be prescribed
• Any patient ineligible for study participation at the discretion of the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone	Methadone hydrochloride	Methadone 0.2-0.25 mg/kg actual body weight
Fentanyl/Hydromorphone	Fentanyl/Hydromorphone	Fentanyl/Hydromorphone per routine care

Primary Outcome Measures

Name	Time	Method
Total amount of opioids medication administered	From PACU discharge through postoperative day 1 (POD1)	Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1

Secondary Outcome Measures

Name	Time	Method
Postanesthesia Care Unit (PACU) opioid medication administration	Up to 6 hours after surgery	Binary (yes/no) need for opioid administration in the PACU
Total amount of opioid medications administered	Up to 7 days after surgery	Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg)
Area under the curve (AUC) pain trajectories	Through hospital discharge (up to 4 days)	In-hospital AUC pain trajectories calculated from pain intensity scores on the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Average daily pain intensity	Up to 7 days after surgery	Average daily pain scores using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States