Clinical trial NCT03375593: Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
Official title: Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Distal Radius Fracture
Pain Management
Metacarpal Fracture
Keywords: pain management
RCT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-12-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Pain
timeFrame: 0-2 weeks
Secondary outcomes:
measure: Drug use
timeFrame: 2 weeks
measure: Pain diary
timeFrame: 2 weeks
measure: Grip strength
timeFrame: 12 weeks
measure: Grip strength
timeFrame: 24 weeks
measure: Pinch strength
timeFrame: 12 weeks
measure: Pinch strength
timeFrame: 24 weeks
measure: Dexterity
timeFrame: 12 and 24 weeks
measure: Range of Motion
timeFrame: 12 and 24 weeks
measure: pain management
timeFrame: 3 weeks
measure: Work Impact
timeFrame: 12 and 24 weeks
measure: Future preference
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph Health Care
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References: