Pediatric Pain Optimization After Tonsillectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2023-05-10

Brief Summary

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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.

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Detailed Description

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This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

Conditions

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Obstructive Sleep Apnea Tonsillitis Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Short acting opioids: Fentanyl, Hydromorphone

Group Type ACTIVE_COMPARATOR

Fentanyl/Hydromorphone

Intervention Type DRUG

Per routine care

Long Acting Opioid: Methadone

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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

Interventions

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Fentanyl/Hydromorphone

Per routine care

Intervention Type DRUG

Methadone

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes