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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcotic | Experimental | Hydrocodone 5mg/Acetaminophen 500 mg Tab |
|
| Non Narcotic | Experimental | Ibuprofen 600mg Tab + acetaminophen 500 mg Tab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone 5Mg/Acetaminophen 500Mg Tab | Drug | tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | PRWE (patient rated wrist evaluation)
| 0-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use | Total medication used will be recorded by a pain diary (for the first 2 weeks) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joy C MacDermid, PhD | Contact | 519-646-6100 | 64636 | jmacderm@uwo.ca |
| Katrina Munro, CRA | Contact | 519-646-6100 | 64640 | katrina.munro@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Joy C MacDermid, PhD | St. Joseph's Health Care London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Health Care | Recruiting | London | Ontario | N6A 4L6 | Canada |
only de-identified data will be available upon request
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participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture pain
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study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs
| Acetaminophen 500Mg Tab | Drug | tablet |
|
|
| Ibuprofen 600 mg tab | Drug | tablet |
|
|
| 2 weeks |
| Grip strength | Grip strength in kg will be measured with calibrated instrument and standardized test positioning. | 12 weeks |
| Grip strength | Grip strength in kg will be measured with calibrated instrument and standardized test positioning. | 24 weeks |
| Pinch strength | pinch strength in kg will be measured with calibrated instrument and standardized test positioning. | 12 weeks |
| Pinch strength | pinch strength in kg will be measured with calibrated instrument and standardized test positioning. | 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. | 12 and 24 weeks |
| Range of Motion | active range of motion will be measured in degrees with standardized test positioning. | 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 | 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) | 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 | 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 | 24 weeks |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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