Comparing pain control methods after tonsil surgery in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.