Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Chi, MD
• Treatments: Acetaminophen; Analgesics, Opioid; Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

• Patients age 3 - 17 undergoing adenotonsillectomy

Exclusion Criteria:

• Down syndrome

• History of coagulopathy

• Craniofacial abnormalities

• Caregivers who cannot speak, read, or write in English proficiently

• Patients who take opioids during the enrollment period

• Patients who take chronic opioids

• Pregnancy

• Allergy to or contraindication for taking any of the study medications

• Patients who have the inability to communicate

• Patients who have the inability to localize pain