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Opioid

Methadone for Pediatric Tonsillectomy Pain

Phase 4

Waitlist Available

Led By Lisa M. Einhorn, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 3 and < 18 years

Elective tonsillectomy +/- adenoidectomy

Must not have

Current diagnosis of a chronic pain disorder

Severe sleep apnea: Apnea Hypopnea Index > 10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days post surgery

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

"This trial aims to see whether short-acting opioids like fentanyl or hydromorphone work as well as long-acting opioids like methadone for managing pain after tonsil removal surgery in

Who is the study for?

This trial is for children and teens aged 3 to under 18 who need tonsillectomy surgery, with or without adenoidectomy. They must consent (if old enough) and have a parent or guardian's permission. Post-pubescent females need a negative pregnancy test. It excludes those with chronic pain disorders, severe sleep apnea, planned PICU admission after surgery, additional procedures needing opioids, or chronic kidney/liver disease.

What is being tested?

The study compares two types of painkillers for managing post-tonsillectomy pain in kids: Methadone (a long-lasting opioid) versus Fentanyl/Hydromorphone (shorter-acting opioids). The goal is to see which provides better pain control.

What are the potential side effects?

Possible side effects include nausea, vomiting, constipation, drowsiness, respiratory depression (slow breathing), itching and potential dependency issues associated with opioid use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 17 years old.

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I am planning to have my tonsils and possibly adenoids removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a chronic pain condition.

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I have severe sleep apnea.

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My child is scheduled for a stay in the Pediatric Intensive Care Unit.

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I will undergo surgery needing general anesthesia and opioids.

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I have a history of chronic kidney or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 days post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 days post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)

Secondary study objectives

Evaluation of participant's pain as measured by Numeric Pain Rating Scale

Number of participants with adverse event in the PACU (post-anesthesia care unit)

Opioid administration in the PACU (post-anesthesia care unit)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Short acting opioids: Fentanyl/HydromorphoneActive Control1 Intervention

Per Routine Care

Group II: Long acting opioid: MethadoneActive Control1 Intervention

Initial Dosing: 0.15 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.2 mg/kg age-ideal body weight in adolescents age 12 - 17 years. Dose escalation (possible, based on interim analysis): 0.2 mg/kg age-ideal body weight in children age 3 - \< 12 years and 0.25 mg/kg age-ideal body weight in adolescents age 12 - 17 years.

0 / 7Eligibility criteria met