NCT06671002

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Surgery
• Pain, Post Operative

Interventions

Type	Name	Description
DRUG	NSAID	Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain: * Ibuprofen 10 milligrams(mg)/kilogram (kg) (maximum 600mg) by mouth every 6 hours around the clock for 2 days, then as needed for pain thereafter (40 doses) * Celecoxib 6mg/kg (maximum 400mg) by mouth once then 3 mg/kg (maximum 200mg) every 12 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)
DRUG	Opioid	Once randomized to this group the surgical team will elect to prescribe for 1 of the following treatment options to be given post procedure for post-discharge pain: * Oxycodone 0.1 mg/kg (maximum 5 mg) by mouth every 4 to 6 hours as needed for pain, number 10 doses. * Hydromorphone 0.04 mg/kg (maximum mg) by mouth 4 to 6 hours as needed, number 10 doses
DRUG	Acetaminophen	Participants will receive 15mg/kg up to 1000mg by mouth every 6 hours around the clock for the first 2 days after discharge from surgery then as needed thereafter (40 doses)
DRUG	Ibuprofen	Ibuprofen 10mg/kg (maximum 600 mg) by mouth every 6 hours around the clock for 2 days after discharge from surgery then as needed thereafter (40 doses)

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-10-16
• Completion: 2027-10-31
• First posted: 2024-11-04
• Last updated: 2026-03-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study