Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Recruiting now · Phase 4

Conditions studied: Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children

In brief

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.

Key facts

Study ID

NCT06962306

Run by

Duke University

People needed

60

Starts

2025-06-04

Expected to finish

2027-07-04

Last updated by the study team

2026-04-14

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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