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

University of Michigan

Status and phase: Enrolling; Phase 4

Conditions: Pain, Post Operative; Surgery

Treatments: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Opioid; Drug: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT06671002

HUM00252793

BPS-2023C1-32147 (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Enrollment: 900 estimated patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No significant analgesic medication use before surgery as defined in the protocol
• Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).

Exclusion criteria

• Anticipated other surgery within 12 months
• Anticipated life expectancy of <12 months
• Those that have legal guardians (due to special permission to enroll in trials)
• Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
• Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
• Liver disease
• Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

900 participants in 2 patient groups

Acetaminophen/NSAID regimen

Other group

Treatment:

Drug: NSAID

Drug: Acetaminophen

Acetaminophen/NSAID/Opioid regimen

Other group

Treatment:

Drug: Opioid

Drug: Acetaminophen

Drug: Ibuprofen