Clinical trial NCT06671002: Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
Official title: Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgery
Pain, Post Operative
Keywords: Medications after surgery
NSAIDS
Acetaminophen
Opioids
Analgesics, non-narcotic
Tonsil removal
Gallbladder removal
Knee scope
Analgesics, opioid
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-11-04
Enrollment: 900
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: 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)

Primary outcomes:
measure: Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
timeFrame: 14 days post-surgery, and up to 12 months after surgery
measure: Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery
timeFrame: 14 days post-surgery, and 1 month after surgery
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a
timeFrame: Baseline and 1 month after surgery
measure: Patient Global Impression of Change (PGIC)
timeFrame: Day 7 up to 12 months after surgery
measure: PROMIS Pediatric Pain Interference scale (Short form-8a)
timeFrame: Baseline up to 12 months after surgery
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline up to 12 months after surgery
measure: Pediatric Quality of Life Inventory Short Form 15
timeFrame: Baseline up to 12 months after surgery
measure: Quality of Recovery (QoR) 15
timeFrame: Day 3, 1 week, and 2 weeks after surgery
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline up to 12 months after surgery
measure: Generalized Anxiety Disorder (GAD-2)
timeFrame: Baseline up to 12 months after surgery
measure: Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use
timeFrame: Baseline up to 12 months after surgery
measure: National Survey on Drug Use and Health Questions on Opioid Misuse
timeFrame: Baseline up to 12 months after surgery
measure: New prolonged opioid use
timeFrame: Up to 12 months after surgery
measure: Acute pain based on The Michigan Body Map
timeFrame: Up to 12 months after surgery
measure: Chronic pain based on Body Map
timeFrame: Up to 12 months after surgery
measure: Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery
timeFrame: to 12 months after surgery
measure: Healthcare Utilization related to pain
timeFrame: Up to 12 months after surgery
measure: Analgesic medication use
timeFrame: Up to 12 months after surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles (CHLA)
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: Nationwide Children's (NCH)
state: Ohio
Study officials:
affiliation: University of Michigan
name: Mark Bicket, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: