Clinical trial

Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study

Name

Pro00109911

Description

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.

Trial arms

Trial start

2022-04-08

Estimated PCD

2023-05-10

Trial end

2023-05-10

Status

Completed

Phase

Early phase I

Treatment

Fentanyl/Hydromorphone

Per routine care

Arms:

Short acting opioids: Fentanyl, Hydromorphone

Methadone

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

Arms:

Long Acting Opioid: Methadone

Size

Primary endpoint

Total amount of opioid medications administered

Up to 7 days post surgery

Eligibility criteria

Inclusion Criteria: * Children ages 3 to 17 years old * Presenting for elective tonsillectomy +/- adenoidectomy * Provide informed consent / assent (as appropriate) Exclusion Criteria: * History of liver or kidney disease * Females with positive pregnancy test * Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) \> 10) * Consistent daily opioid use for chronic pain ( \>3 months)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

Updated at

2023-12-01

1 organization

2 products

4 indications

Organization

Duke University

Product

Fentanyl/Hydromorphone

Indication

Obstructive Sleep Apnea

Indication

Indication

Indication

Product