Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen 500Mg Tab
- Conditions
- Distal Radius Fracture
- Sponsor
- Lawson Health Research Institute
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Pain
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Narcotic
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Intervention: Acetaminophen 500Mg Tab
Narcotic
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Intervention: Ibuprofen 600 mg tab
Non Narcotic
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
Intervention: Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Outcomes
Primary Outcomes
Pain
Time Frame: 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 Outcomes
- Pain diary(2 weeks)
- Grip strength(24 weeks)
- Dexterity(12 and 24 weeks)
- Adverse events(24 weeks)
- Drug use(2 weeks)
- Pinch strength(24 weeks)
- Range of Motion(12 and 24 weeks)
- pain management(3 weeks)
- Work Impact(12 and 24 weeks)
- Future preference(24 weeks)