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

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

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Distal Radius Fracture; Metacarpal Fracture
• Intervention / Treatment: Drug: Acetaminophen 500Mg Tab; Drug: Ibuprofen 600 mg tab; Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joy C MacDermid, PhD; Phone Number: 64636 519-646-6100; Email: jmacderm@uwo.ca
• Study Contact Backup: Name: Katrina Munro, CRA; Phone Number: 64640 519-646-6100; Email: katrina.munro@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Recruiting
      • St. Joseph Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narcotic; Hydrocodone 5mg/Acetaminophen 500 mg Tab	Drug: Acetaminophen 500Mg Tab; tablet; Other Names: tylenol; Drug: Ibuprofen 600 mg tab; tablet; Other Names: advil
Experimental: Non Narcotic; Ibuprofen 600mg Tab + acetaminophen 500 mg Tab	Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab; tablet; Other Names: oxycodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	PRWE (patient rated wrist evaluation); 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; 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	0-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug use	Total medication used will be recorded by a pain diary (for the first 2 weeks)	2 weeks
Pain diary	participants will be provided a pain diary (for the first 2 weeks) that includes the numeric pain rating scale (NRS), where they can record when they take their medication and the NRS at each self-administration. will use a 0-10 scale where 0 means no pain and 10 is the worst imaginable pain	2 weeks
Grip strength	Grip strength in kg will be measured with calibrated instrument and standardized test positioning.	12 weeks
Grip strength	Grip strength in kg will be measured with calibrated instrument and standardized test positioning.	24 weeks
Pinch strength	pinch strength in kg will be measured with calibrated instrument and standardized test positioning.	12 weeks
Pinch strength	pinch strength in kg will be measured with calibrated instrument and standardized test positioning.	24 weeks
Dexterity	dexterity will be tested with a standardized test. dexterity is a timed, in seconds, test. the participant is asked to move small objects from one spot to another.	12 and 24 weeks
Range of Motion	active range of motion will be measured in degrees with standardized test positioning.	12 and 24 weeks
pain management	Patient satisfaction with pain management will be measured using a single item satisfaction NRS. using a 0-10 scale where 0 is very unsatisfied and 10 is very satisfied	3 weeks
Work Impact	Time to return to work will be collected and the Work Limitations Questionnaire will be administered at return to work, 12 and 24 weeks to determine the work impacts of interventions. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time)	12 and 24 weeks
Future preference	Preference for future pain management. Patients will be asked if they were to have another fracture, would they prefer to have the same or a different pain medication. They will also be asked what medication they thought they were taking so we can assess how this impacts on their preference, and to discern whether patients were aware of their allocation	24 weeks
Adverse events	Adverse events or complications will be recorded using a standardized complications checklist and a standardized adverse event reporting form completed by their surgeon at each time point	24 weeks

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Joy C MacDermid, PhD, St. Joseph's Health Care London

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: RCT; pain management
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ibuprofen; Oxycodone; Hydrocodone
• Other Study ID Numbers: REB 1090503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only de-identified data will be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No