RECRUITING

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2024-12-11
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06671002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * No significant analgesic medication use before surgery as defined in the protocol
  2. * Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
  1. * Anticipated other surgery within 12 months
  2. * Anticipated life expectancy of \<12 months
  3. * Those that have legal guardians (due to special permission to enroll in trials)
  4. * Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
  5. * 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.
  6. * Liver disease
  7. * 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)

Contacts and Locations

Study Contact

Sarah Clark
CONTACT
734-232-0324
sarahmcl@umich.edu

Principal Investigator

Mark Bicket, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Children's Hospital Los Angeles (CHLA)
Los Angeles, California, 90027
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Nationwide Children's (NCH)
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Mark Bicket, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

  • Medications after surgery
  • NSAIDS
  • Acetaminophen
  • Opioids
  • Analgesics, non-narcotic
  • Tonsil removal
  • Gallbladder removal
  • Knee scope
  • Analgesics, opioid

Additional Relevant MeSH Terms

  • Surgery
  • Pain, Post Operative