Pediatric Pain Optimization After Tonsillectomy

Study Overview
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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.

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.

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

Conditions
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Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural

Intervention / Treatment
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* Drug: Fentanyl/Hydromorphone
* Drug: Methadone


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short acting opioids: Fentanyl, Hydromorphone<br> | Drug: Fentanyl/Hydromorphone<br>* Per routine care<br>|
| Active Comparator: Long Acting Opioid: Methadone<br> | Drug: Methadone<br>* Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of opioid medications administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Up to 7 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of participant's pain as measured by Parent Post operative Pain Measure (PPPM) | Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain. | Up to 7 days post surgery | 
| NIH PROMIS Parent Proxy Report Scale | Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always | Up to 7 days post surgery | 
| Evaluation of participant's pain as measured by Numeric Pain Rating Scale | Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain | Up to 7 days post surgery | 
| Prescription opioid use following hospital discharge | Number of doses of prescription medication used, 0 doses-all doses in prescription | Up to 7 days post surgery | 
| Opioid administration in the PACU (post-anesthesia care unit) | Opioid medication use in the recovery room expressed in morphine equivalents per kilogram | Up to 6 hours post surgery |