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RecruitingAccepts healthy volunteersPhase 4

Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Duke University · with National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06576830

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–17 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
440
US sites recruiting
1
Study start
November 21, 2024
Record last updated
December 5, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Methadone; Fentanyl/Hydromorphone

Conditions: Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis; Pediatric Sleep Apnea; Sleep-Disordered Breathing

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Duke University Medical Center

    Durham, NC 27710

    Site contact: Lisa Einhorn · lisa.einhorn@duke.edu

Study contacts (from the official record)

  • Lisa M Einhorn, MD · 9196814877 · lisa.einhorn@duke.edu
All sleep studies in North Carolina →
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia (NCT06576830) | Bored Studies