NCT06576830 Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
| NCT ID | NCT06576830 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 440 participants in total. It began in 2024-11-21 with a primary completion date of 2028-12-31.
⚠ 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 tonsillectomy surgery in children and adolescents.
Eligibility Criteria
Inclusion Criteria: 1. Age \>= 3 and \< 18 years 2. Elective tonsillectomy +/- adenoidectomy 3. Signed informed consent by parent or legal guardian 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent 5. Negative pregnancy test within 48 hours for post pubescent females Exclusion Criteria: 1. History of chronic kidney or liver disease 2. Current diagnosis of a chronic pain disorder 3. Planned admission to the Pediatric Intensive Care Unit (PICU) 4. Additional procedures under general anesthesia for which opioids would be prescribed
Contact & Investigator
Lisa M. Einhorn, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06576830 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Pain, Postoperative. 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 NCT06576830 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 NCT06576830 currently recruiting?
Yes, NCT06576830 is actively recruiting participants. Contact the research team at lisa.einhorn@duke.edu for enrollment information.
Where is the NCT06576830 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06576830 clinical trial?
NCT06576830 is sponsored by Duke University. The principal investigator is Lisa M. Einhorn, MD at Duke University. The trial plans to enroll 440 participants.