Status:
RECRUITING
Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Lead Sponsor:
Duke University
Conditions:
Cleft Palate
Pain
Eligibility:
All Genders
6-4 years
Phase:
PHASE4
Brief 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 you...
Detailed Description
This is a single center, randomized, double blind, parallel-group dose escalation investigation in infants and children undergoing cleft palate surgery which will compare post operative pain control i...
Eligibility Criteria
Inclusion
- Age 6 months to 4 years of age
- Primary cleft palate repair
- Signed informed consent by parent or legal guardian
Exclusion
- 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
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 4 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06962306
Start Date
June 4 2025
End Date
July 4 2027
Last Update
June 13 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705