NCT03375593

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

Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture
• Pain Management
• Metacarpal Fracture

Interventions

Type	Name	Description
DRUG	Hydrocodone 5Mg/Acetaminophen 500Mg Tab	tablet
DRUG	Acetaminophen 500Mg Tab	tablet
DRUG	Ibuprofen 600 mg tab	tablet

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2017-12-18
• Last updated: 2021-03-01

Locations

1 site across 1 country: Canada