Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Distal Radius Fracture
  • Metacarpal Fracture
  • Pain Management
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture painMasking: Double (Participant, Investigator)Masking Description: study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packsPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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 + acetam...

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.

Tracking Information

NCT #
NCT03375593
Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Joy C MacDermid, PhD St. Joseph's Health Care London