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Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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

Who can join

6 Months – 4 Years · All sexes

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

About the study

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.

What is being tested

• Methadone hydrochloride (drug)
• Fentanyl/Hydromorphone (drug)

Sponsor: Duke University · Participants: 60 · Started: Jun 4, 2025

Contact the study team

• Lisa M. Einhorn, M.D. · Phone: 919 970 2805

Official record on ClinicalTrials.gov — NCT06962306

Locations in the U.S.

Conditions

• Cleft Lip and Palate
• Pain

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.