Pediatric Pain Optimization After Tonsillectomy

Duke University

Status and phase: Completed; Phase 2

Conditions: Tonsillitis; Obstructive Sleep Apnea; Pain, Procedural

Treatments: Drug: Fentanyl/Hydromorphone; Drug: Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT05244226

Pro00109911

Details and patient eligibility

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

Short acting opioids: Fentanyl, Hydromorphone

Active Comparator group

Treatment:

Drug: Fentanyl/Hydromorphone

Long Acting Opioid: Methadone

Active Comparator group

Treatment:

Drug: Methadone