NCT06962306 Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
| NCT ID | NCT06962306 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Cleft Palate |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2027-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-06-04 with a primary completion date of 2027-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 young children.
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 general anesthesia for which opioids would be prescribed * Any patient ineligible for study participation at the discretion of the investigators
Contact & Investigator
Lisa M. Einhorn, M.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06962306 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 4 Years, studying Cleft Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06962306 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06962306 currently recruiting?
Yes, NCT06962306 is actively recruiting participants. Contact the research team at lisa.einhorn@duke.edu for enrollment information.
Where is the NCT06962306 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06962306 clinical trial?
NCT06962306 is sponsored by Duke University. The principal investigator is Lisa M. Einhorn, M.D. at Duke University. The trial plans to enroll 60 participants.