Comparing pain control methods after tonsil surgery in children
Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial
PHASE4 · Duke University · NCT06576830
This study is testing whether long-lasting pain medicine like methadone works better than short-lasting options like fentanyl and hydromorphone for controlling pain in kids and teens after tonsil surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06576830 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of long-acting opioids, specifically methadone, versus short-acting opioids like fentanyl and hydromorphone for managing postoperative pain in children and adolescents undergoing tonsillectomy. It is a randomized, double-blind, parallel-group trial that will include participants aged 3 to 17 years, who will be assigned to either methadone or short-acting opioids. The study will monitor pain management outcomes and potential side effects through daily surveys and follow-up calls for six months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 3 to 17 years scheduled for elective tonsillectomy with or without adenoidectomy.
Not a fit: Patients with chronic pain disorders, severe sleep apnea, or those requiring admission to the Pediatric Intensive Care Unit may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pediatric tonsillectomy patients, reducing the need for rescue opioids.
How similar studies have performed: Previous studies have explored opioid management in postoperative settings, but this specific comparison of methadone versus short-acting opioids in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Lisa M. Einhorn, MD — Duke University
- Study coordinator: Lisa M Einhorn, MD
- Email: lisa.einhorn@duke.edu
- Phone: 9196814877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis, Pediatric Sleep Apnea, Sleep-Disordered Breathing, Methadone, Tonsillectomy, Opioid