← Back to Search

Non-Opioid Analgesic

Acetaminophen for Musculoskeletal Injuries (No OUCH Trial)

Phase 2
Waitlist Available
Led By Samina Ali, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 30, 60, 90, and 120 minutes post study drug administration, and at the time of medical examination (approximately 90 minutes after time of recruitment) and time of x-ray (approximately 60 minutes after time of recruitment)
Awards & highlights

No OUCH Trial Summary

This trial is testing 3 different possible medication combinations for the pain management of children with acute musculoskeletal (MSK) limb injuries.

Eligible Conditions
  • Musculoskeletal Injuries

No OUCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 30, 60, 90, and 120 minutes post study drug administration, and at the time of medical examination (approximately 90 minutes after time of recruitment) and time of x-ray (approximately 60 minutes after time of recruitment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, 30, 60, 90, and 120 minutes post study drug administration, and at the time of medical examination (approximately 90 minutes after time of recruitment) and time of x-ray (approximately 60 minutes after time of recruitment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
vNRS Pain Score
Secondary outcome measures
Additional Analgesic Requirements
Adverse Events
Between Group Pain Scores
+11 more

No OUCH Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Opioid Trial: Arm 3Experimental Treatment3 Interventions
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone (0.05mg/kg, maximum 5 mg), all administered once during the study at the time of recruitment.
Group II: Opioid Trial: Arm 2Experimental Treatment3 Interventions
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg) + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Group III: Non-Opioid Trial: Arm 2Experimental Treatment2 Interventions
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg), both administered once during the study at the time of recruitment.
Group IV: Opioid Trial: Arm 1Active Control3 Interventions
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Group V: Non-Opioid Trial: Arm 1Active Control2 Interventions
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo, both administered once during the study at the time of recruitment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Hydromorphone placebo
2019
Completed Phase 2
~710
Hydromorphone
2005
Completed Phase 4
~4340
Ibuprofen
2013
Completed Phase 4
~5800
Acetaminophen placebo
2019
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
318,540 Total Patients Enrolled
The University of Western OntarioUNKNOWN
Centre hospitalier de l'Université de Montréal (CHUM)OTHER
370 Previous Clinical Trials
129,159 Total Patients Enrolled
~117 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top