drugset / Trial / NCT03618823

Non-opioids for Analgesia After Adenotonsillectomy in Children

NCT03618823

Phase 1/2 Terminated 268 enrolled David Chi, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after adenotonsillectomy surgery in children. The investigators will be 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 adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.

Timeline

Start
2018-10-25
Primary completion
2020-05-18
Completion
2020-05-18

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxycodone Other / unclassified 0.025 mg/kg
Subject Oxycodone Other / unclassified 0.1 mg/kg
Background Acetaminophen Small molecule 15 mg/kg
Background Ibuprofen Small molecule 10 mg/kg

Indications