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NCT06962306PHASE4Recruiting

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Duke University

Start Date

6/4/2025

Completion Date

7/4/2027

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.

Eligibility Criteria

Age Range: No minimum to 4 years

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

Interventions

DRUG

Methadone hydrochloride

DRUG

Fentanyl/Hydromorphone

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Conditions

Cleft PalatePainPostoperative CarePerioperative CareChildren

Locations

Duke University Medical Center

Durham, North Carolina 27705

United States