Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Launched by DUKE UNIVERSITY · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how to best manage pain after cleft palate surgery in young children. Researchers want to compare two types of pain medications: short-acting opioids like fentanyl and hydromorphone, and a long-acting opioid called methadone. The goal is to find out which option helps control pain better for infants and toddlers following this surgery.

To be eligible for this study, children must be between 6 months and 4 years old and be having surgery to repair a cleft palate. Parents or guardians will need to sign a consent form to allow their child to participate. It's important to note that children with certain health issues, like chronic kidney or liver disease, or those who may need to stay in the Pediatric Intensive Care Unit after surgery, cannot participate. If enrolled, children will receive one of the two types of medication to help manage their pain after the procedure. The findings from this study could help improve how pain is treated for young patients undergoing cleft palate repair.

Gender

ALL

Eligibility criteria

• 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