RecruitingPhase 4

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

United States60 participantsStarted 2025-06-04

Plain-language 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.

Who can participate

Age range6 Months – 4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Total amount of opioids medication administered

Timeframe: From PACU discharge through postoperative day 1 (POD1)

Trial details

NCT IDNCT06962306

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-04

Contact for this trial

Lisa M. Einhorn, M.D.

919 970 2805 lisa.einhorn@duke.edu

View on ClinicalTrials.gov More Cleft Palate trials