Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures

Lawson Health Research Institute

Status and phase: Unknown; Phase 4

Conditions: Metacarpal Fracture; Pain Management; Distal Radius Fracture

Treatments: Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab; Drug: Ibuprofen 600 mg tab; Drug: Acetaminophen 500Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03375593

REB 1090503

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Narcotic

Experimental group

Description:

Hydrocodone 5mg/Acetaminophen 500 mg Tab

Treatment:

Drug: Acetaminophen 500Mg Tab

Drug: Ibuprofen 600 mg tab

Non Narcotic

Experimental group

Description:

Ibuprofen 600mg Tab + acetaminophen 500 mg Tab

Treatment:

Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab