Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-4
SponsorDuke University
About this trial
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 criteria
Qualifiers
Age 6 months to 4 years of age
Primary cleft palate repair
Signed informed consent by parent or legal guardian
Disqualifiers
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
Trial design
Treatments tested in this trial
- Methadone hydrochloride
- Fentanyl/Hydromorphone
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
1Duke University Medical Center27705, DurhamNorth Carolina, United States
Sponsors and collaborators
Duke University
Lead sponsor
Source ClinicalTrials.gov