Comparing pain relief options for children after surgery
Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial
This study tests which pain relief method works better for kids recovering from surgery: a mix of common pain relievers or a low dose of opioids with those pain relievers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT06671002 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness and safety of two pain management regimens for children recovering from surgery. Participants who undergo elective tonsil removal, gallbladder removal, or knee arthroscopy will be randomly assigned to receive either a combination of NSAIDs and acetaminophen or a low dose of opioids along with NSAIDs and acetaminophen. The study aims to determine which medication regimen provides better pain relief with fewer side effects.
Who should consider this trial
Good fit: Ideal candidates are children undergoing elective tonsil removal, gallbladder removal, or knee arthroscopy who have not used significant analgesic medications prior to surgery.
Not a fit: Patients with complex chronic conditions, contraindications to the study medications, or those requiring additional surgeries within the next year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children after surgery, enhancing their recovery experience.
How similar studies have performed: Other studies have explored pain management in pediatric surgery, but this specific comparison of NSAIDs and opioids in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6 days or more of opioid medications in the past 90 days (aligning with American Pediatric Guidelines that were published in September 2024 after the project was funded), excepting surgical team prescriptions within the week of surgery. * Undergo one the following: 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)
Where this trial is running
Los Angeles, California and 3 other locations
- Children's Hospital Los Angeles (CHLA) — Los Angeles, California, United States (Recruiting)
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Nationwide Children's (NCH) — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mark Bicket, MD, PhD — University of Michigan
- Study coordinator: Sarah Clark
- Email: sarahmcl@umich.edu
- Phone: 734-232-0324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.