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Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

NCT06576830 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Tonsillar Hypertrophy
  • Tonsillitis
  • Pediatric Sleep Apnea
  • Sleep-Disordered Breathing

Interventions

DRUG

Methadone

Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.

DRUG

Fentanyl/Hydromorphone

Per routine care, given as needed

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Lisa M. Einhorn, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2028-12-31
Completion
2029-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576830 on ClinicalTrials.gov