Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

Summary

The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after intracapsular adenotonsillectomy surgery in children. This study is the second part of our randomized clinical trials of assessing pain after adenotonsillectomy (T\&A), the first being total T\&A. The investigators will repeat the methodology in the first clinical trial by randomly assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain medication only, and the other group will receive opioid and non-opioid medications for pain control. The investigators will analyze the data and determine if there is a difference in pain control between the two drug regimens, and if there are any other associated complications between the two groups.

This study is important because if we can demonstrate that there is little difference in outcomes and pain control between the two groups, a strong argument can be made for reducing or eliminating opioid prescription after intracapsular adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.

Conditions

• Adenotonsillectomy
• Post-operative Analgesia
• Opioid Use

Interventions

DRUG

Oxycodone

Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

DRUG

Ibuprofen

Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

DRUG

Acetaminophen

Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

OTHER

Opioid disposal pouch

Half of the opioid group will be randomized assigned to an opioid disposal pouch arm. This pouch is a drug deactivation system that can be disposed in the trash in a household.

OTHER

Opioid disposal education

An opioid disposal education document will be provided to all families in the opioid group. This education document has information on unused or expired prescription medication disposal and specific information about permanent collection sites within our health system, drug take-back locations, drug take back day, and disposing at home.

Sponsors & Collaborators

• David Chi, MD

  lead OTHER

Principal Investigators

• David H Chi, MD · Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-13

Primary Completion

2023-07-03

Completion

2023-07-03

FDA Drug

Yes

Countries

• United States

Study Locations