Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
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|ClinicalTrials.gov Identifier: NCT03375593|
Recruitment Status : Not yet recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture Pain Management Metacarpal Fracture||Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab Drug: Acetaminophen 500Mg Tab Drug: Ibuprofen 600 mg tab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture pain|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs|
|Official Title:||Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2020|
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Drug: Acetaminophen 500Mg Tab
Other Name: tylenol
Drug: Ibuprofen 600 mg tab
Other Name: advil
Experimental: Non Narcotic
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Other Name: oxycodone
- Pain [ Time Frame: 0-2 weeks ]
PRWE (patient rated wrist evaluation)
- 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
- 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
- Drug use [ Time Frame: 2 weeks ]Total medication used will be recorded by a pain diary (for the first 2 weeks)
- Pain diary [ Time Frame: 2 weeks ]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
- Grip strength [ Time Frame: 12 weeks ]Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
- Grip strength [ Time Frame: 24 weeks ]Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
- Pinch strength [ Time Frame: 12 weeks ]pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
- Pinch strength [ Time Frame: 24 weeks ]pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
- Dexterity [ Time Frame: 12 and 24 weeks ]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.
- Range of Motion [ Time Frame: 12 and 24 weeks ]active range of motion will be measured in degrees with standardized test positioning.
- pain management [ Time Frame: 3 weeks ]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
- Work Impact [ Time Frame: 12 and 24 weeks ]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)
- Future preference [ Time Frame: 24 weeks ]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
- Adverse events [ Time Frame: 24 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375593
|Contact: Joy C MacDermid, PhD||519-646-6100 ext firstname.lastname@example.org|
|Contact: Katrina Munro, CRA||519-646-6100 ext email@example.com|
|St. Joseph Health Care|
|London, Ontario, Canada, N6A 4L6|
|Principal Investigator:||Joy C MacDermid, PhD||St. Joseph's Health Care London|