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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 weeks3 visits

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)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

318,536 Total Patients Enrolled

The University of Western OntarioUNKNOWN

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

366 Previous Clinical Trials

128,927 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what population is this clinical trial open?

"To qualify for this trial, applicants must have musculoskeletal injuries and fall within the age bracket of 6 to 17 years old. This medical research is intending to include 536 participants."

Answered by AI

Are participants of any age eligible for this trial?

"To qualify for this study, applicants must be aged between 6 and 17 years old. This particular trial is one of 161 studies targeting those under 18 whereas there are 673 trials available to individuals over the age of 65."

Answered by AI

Are any other investigations being conducted regarding Acetaminophen's effects?

"Presently, there are 120 active medical investigations into Acetaminophen with 35 trials in their third phase. These studies can be found across 1,046 locations around the world; however, many of them are concentrated in Boston."

Answered by AI

How many facilities are overseeing this research program?

"6 medical sites are currently enrolling for this trial, including Children's Hospital of London Health Sciences in London, the Children's Hospital of Winnipeg and Alberta Children's Hospital located in Calgary. There are also 3 additional locations taking part."

Answered by AI

Is this experiment presently enrolling participants?

"Data on clinicaltrials.gov suggested that this medical trial is currently in need of participants, having been posted on April 20th 2019 and revised most recently on October 3rd 2022."

Answered by AI

What is the size of the sample population enrolled in this clinical trial?

"This clinical trial necessitates the enrollment of 536 patients whose medical profiles satisfy all inclusion criteria. Those that pass this preliminary bar can participate from either Children's Hospital at London Health Sciences in London, Manitoba or Children's Hospital of Winnipeg located near Winnipeg, Alberta."

Answered by AI

Has Acetaminophen been officially recognized by the Food and Drug Administration?

"Although there is evidence of safety for Acetaminophen, since this trial only falls under Phase 2 classification, which lacks efficacy data, its score was set at a conservative 2."

Answered by AI

What maladies can Acetaminophen provide relief for?

"Acetaminophen is the usual treatment for catarrh. Furthermore, it can be beneficial in alleviating rhinorrhoea, musculoskeletal pain, and muscle spasms."

Answered by AI