Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Start Date
6/4/2025
Completion Date
7/4/2027
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.
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 indices for patients receiving short acting versus long acting opioids as perioperative analgesics. Surgical and anesthesia care, except for opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.
Eligibility Criteria
Age Range: No minimum to 4 years
Interventions
Methadone hydrochloride
Fentanyl/Hydromorphone
Conditions
Locations
Duke University Medical Center
Durham, North Carolina 27705
United States