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 treatment provides the most effective pain relief
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 that is not unacceptably worse than the most commonly prescribed narcotic (hydrocodone 5 mg + acetaminophen 500 mg) in patients with a hand or wrist fracture. 2. the following covariates affect pain outcomes: sex/gender, age, gender-related pain expectations, paid/unpaid work roles, comorbid health status, baseline pain intensity, and employment status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
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St. Joseph Health Care
London, Ontario, Canada
RECRUITINGPain
PRWE (patient rated wrist evaluation) 1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0
Time frame: 0-2 weeks
Drug use
Total medication used will be recorded by a pain diary (for the first 2 weeks)
Time frame: 2 weeks
Pain diary
participants will be provided a pain diary (for the first 2 weeks) that includes the numeric pain rating scale (NRS), where they can record when they take their medication and the NRS at each self-administration. will use a 0-10 scale where 0 means no pain and 10 is the worst imaginable pain
Time frame: 2 weeks
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Time frame: 12 weeks
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Time frame: 24 weeks
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Time frame: 12 weeks
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
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Time frame: 24 weeks
Dexterity
dexterity will be tested with a standardized test. dexterity is a timed, in seconds, test. the participant is asked to move small objects from one spot to another.
Time frame: 12 and 24 weeks
Range of Motion
active range of motion will be measured in degrees with standardized test positioning.
Time frame: 12 and 24 weeks
pain management
Patient satisfaction with pain management will be measured using a single item satisfaction NRS. using a 0-10 scale where 0 is very unsatisfied and 10 is very satisfied
Time frame: 3 weeks
Work Impact
Time to return to work will be collected and the Work Limitations Questionnaire will be administered at return to work, 12 and 24 weeks to determine the work impacts of interventions. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time)
Time frame: 12 and 24 weeks
Future preference
Preference for future pain management. Patients will be asked if they were to have another fracture, would they prefer to have the same or a different pain medication. They will also be asked what medication they thought they were taking so we can assess how this impacts on their preference, and to discern whether patients were aware of their allocation
Time frame: 24 weeks
Adverse events
Adverse events or complications will be recorded using a standardized complications checklist and a standardized adverse event reporting form completed by their surgeon at each time point
Time frame: 24 weeks