Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Phase 4 Recruiting 900 enrolled University of Michigan Patient-Centered Outcomes Research Institute · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?

Timeline

Start: 2025-01-10
Primary completion: 2026-10-16
Completion: 2027-10-31

Publications

Lee JS, Bicket MC, Mansfield SA, Rabbitts JA, Van Horn A, Perrone EE, Chua KP, Voepel-Lewis T, Waljee J, Brummett C, Hutmacher C, Li Y, Kelley-Quon LI; CARES for Kids Investigators. US multicentre randomised controlled trial protocol: Comparing Analgesic Regimen Effectiveness and Safety after surgery trial for Kids (CARES for Kids). BMJ Open. 2026 May 28;16(5):e118728. doi: 10.1136/bmjopen-2026-118728.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	3 mg/kg	Oral
Subject	Hydromorphone	Other / unclassified	0.04 mg/kg	Oral
Subject	Ibuprofen	Small molecule	10 mg/kg	Oral
Subject	Oxycodone	Other / unclassified	0.1 mg/kg	Oral
Background	Acetaminophen	Small molecule	15 mg/kg	Oral

Indications

No indication recorded.