RecruitingPhase 4NCT06962306
Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
Sponsor
Duke University
Enrollment
60 participants
Start Date
Jun 4, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 6 MonthsMax Age: 4 Years
Inclusion Criteria3
- Age 6 months to 4 years of age
- Primary cleft palate repair
- Signed informed consent by parent or legal guardian
Exclusion Criteria4
- 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
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Interventions
DRUGMethadone hydrochloride
Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
DRUGFentanyl/Hydromorphone
Per routine care
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06962306
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