Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Recruiting
Phase 4
Interventional Study
Cleft Palate
Pain
Postoperative Care
Perioperative Care
Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 4
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Duke University · Other
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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.
Trial Locations
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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 g…
Contacts