Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
- Conditions
- Metacarpal FracturePain ManagementDistal Radius Fracture
- Interventions
- Registration Number
- NCT03375593
- Lead Sponsor
- Lawson Health Research Institute
- 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 treatment provides the most effective pain relief
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Narcotic Acetaminophen 500Mg Tab Hydrocodone 5mg/Acetaminophen 500 mg Tab Non Narcotic Hydrocodone 5Mg/Acetaminophen 500Mg Tab Ibuprofen 600mg Tab + acetaminophen 500 mg Tab Narcotic Ibuprofen 600 mg tab Hydrocodone 5mg/Acetaminophen 500 mg Tab
- Primary Outcome Measures
Name Time Method Pain 0-2 weeks 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
- Secondary Outcome Measures
Name Time Method pain management 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
Pain diary 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 24 weeks Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Dexterity 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.
Adverse events 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
Drug use 2 weeks Total medication used will be recorded by a pain diary (for the first 2 weeks)
Pinch strength 24 weeks pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Range of Motion 12 and 24 weeks active range of motion will be measured in degrees with standardized test positioning.
Work Impact 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 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
Trial Locations
- Locations (1)
St. Joseph Health Care
🇨🇦London, Ontario, Canada