A Phase 4 interventional study of Hydrocodone 5Mg/Acetaminophen 500Mg Tab and Acetaminophen 500Mg Tab in Distal Radius Fracture, Pain Management and Metacarpal Fracture, sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's · Phase 4, Interventional, and Treatment
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.
330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.
This study's planned enrollment of 250 is above the median of 62 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →London Health Sciences Centre OR Lawson Research Institute of St. Joseph's is the lead sponsor of 25 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Drug: Acetaminophen 500Mg Tab · Drug: Ibuprofen 600 mg tab
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Drug page: Hydrocodone
tablet
Also known as: oxycodone
tablet
Also known as: tylenol
tablet
Also known as: advil
Pain
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.
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
Plan to share: No — only de-identified data will be available upon request
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydrocodone · Acetaminophen · Ibuprofen
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's