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CARES for Kids: Analgesic Regimen Effectiveness and Safety for Surgery
NCT06671002Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- University of Michigan
- Modality
- Orthosteric Ligands
- Drugs
- morphine
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, open-label trial of morphine in postoperative pain (2 arms), sponsored by University of Michigan. Primary endpoints: Brief Pain Inventory pain intensity score at 12 months and Number and severity of any adverse medication-related symptoms at 1 month. Started Jan 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Acetaminophen/NSAID regimen
Participants receive Acetaminophen and an NSAID (Ibuprofen or Celecoxib).
Acetaminophen/NSAID/Opioid regimen
Participants receive Acetaminophen, an NSAID (Ibuprofen), and an Opioid (Oxycodone or Hydromorphone).
03
Who it enrols
Children undergoing tonsil removal, gallbladder removal, or knee scope, without significant prior opioid use, complex chronic conditions, liver disease, or acute psychiatric instability.
04
Endpoints
Primary
Brief Pain Inventory pain intensity score
Number and severity of any adverse medication-related symptoms
Secondary
PROMIS Pediatric Sleep Disturbance v1.0 short form 4a
Patient Global Impression of Change
PROMIS Pediatric Pain Interference scale (Short form-8a)
Pain Catastrophizing Scale
Pediatric Quality of Life Inventory Short Form 15
Quality of Recovery 15
Patient Health Questionnaire
Generalized Anxiety Disorder
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