drugset / Trial / NCT05722002
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) 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 surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen). It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.
Timeline
- Start
- 2023-02-06
- Primary completion
- 2026-12
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 200 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 2 mg | Oral |
| Subject | Ibuprofen | Small molecule | 600 mg | Oral |
| Subject | Morphine | Other / unclassified | 7.5 mg | Oral |
| Subject | Naproxen | Small molecule | 250 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 5 mg | Oral |
| Background | Acetaminophen | Small molecule | 1000 mg | Oral |