Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

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?

Conditions

Surgery, Pain, Post Operative

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Study Overview

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Study Details

Study overview

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?

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

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles (CHLA), Los Angeles, California, United States, 90027

Palo Alto

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States, 94304

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Columbus

Nationwide Children's (NCH), Columbus, Ohio, United States, 43205

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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)

Ages Eligible for Study

12 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

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

Study Record Dates

2027-10-31