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Pediatric Pain Optimization After Tonsillectomy

NCT05244226 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-10-17

Study results available
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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.

Conditions

Interventions

DRUG

Fentanyl/Hydromorphone

Per routine care

DRUG

Methadone

Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis

Sponsors & Collaborators

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
2022-04-08
Primary Completion
2023-05-10
Completion
2023-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT05244226 on ClinicalTrials.gov