RecruitingPhase 4NCT06962306

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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

Sponsor

Duke University

Enrollment

60 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Cleft Palate Perioperative Care Children Postoperative Care

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.

Eligibility

Min Age: 6 MonthsMax Age: 4 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

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Interventions

DRUGMethadone hydrochloride

Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis

DRUGFentanyl/Hydromorphone

Per routine care

Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT06962306

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