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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fentanyl/Hydromorphone and a drug called Methadone hydrochloride for people with children, cleft palate, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Months to 4 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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