Status:
UNKNOWN
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Distal Radius Fracture
Pain Management
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate two drug options for pain control in patients following wrist injury. Participants will be randomized to one of the 2 pain relief treatments to determine what ...
Detailed Description
The purposes of this noninferiority randomized clinical trial are to determine whether: 1. the most commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 500 mg) provides pain relief ...
Eligibility Criteria
Inclusion
- All patients 18 and older undergoing non-operative management of a hand or wrist fracture will be considered eligible.
- Able to read and speak English
Exclusion
- pain exceeding 7/10 on numeric rating scale or 35/50 on PRWE pain scale at enrollment
- nerve injury
- surgeon decision that surgery is required
- history of chronic opioid use
- documented or suspected substance abuse
- individuals currently on daily use of ibuprofen, acetaminophen or other pain-altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
- individuals with documented or suspected chronic pain syndrome, reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen
- history or symptoms of serious medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
- patients with active peptic ulcer disease (history of severe heartburn)
- symptoms of infection
- pregnant or lactating women
- diagnosis of cognitive impairment
- unable to provide informed consent
- unable or unwilling to fill out the forms
- prior fracture in same hand
- on Coumadin or Plavix
- other medical or psychological health conditions that preclude them from receiving either intervention
- or unable to return for follow-up visits
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03375593
Start Date
August 1 2019
End Date
October 1 2022
Last Update
March 1 2021
Active Locations (1)
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1
St. Joseph Health Care
London, Ontario, Canada, N6A 4L6