RecruitingPhase 4

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

United States440 participantsStarted 2024-11-21

Plain-language 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.

Who can participate

Age range3 Years – 17 Years

SexALL

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Inclusion criteria

✓. Age \>= 3 and \< 18 years
✓. Elective tonsillectomy +/- adenoidectomy
✓. Signed informed consent by parent or legal guardian
✓. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
✓. Negative pregnancy test within 48 hours for post pubescent females

Exclusion criteria

✕. History of chronic kidney or liver disease
✕. Current diagnosis of a chronic pain disorder
✕. Planned admission to the Pediatric Intensive Care Unit (PICU)
✕. Additional procedures under general anesthesia for which opioids would be prescribed

What they're measuring

Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)

Timeframe: Up to 6 hours post surgery

Trial details

NCT IDNCT06576830

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Lisa M Einhorn, MD

9196814877 lisa.einhorn@duke.edu

View on ClinicalTrials.gov More Pain, Postoperative trials