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

NCT03375593 | Unknown Phase 4 DMC

• 1 other identifier: REB 1090503
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Distal Radius Fracture; Pain Management; Metacarpal Fracture

Keywords

pain management; RCT

Outcome Measures

Primary Outcomes (1)

• Pain

  PRWE (patient rated wrist evaluation) 1. 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 2. 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 Outcomes (12)

• Drug use

  2 weeks

• Pain diary

  2 weeks

• Grip strength

  12 weeks

• Grip strength

  24 weeks

• Pinch strength

  12 weeks

Study Arms (2)

Narcotic

EXPERIMENTAL

Hydrocodone 5mg/Acetaminophen 500 mg Tab

Drug: Acetaminophen 500Mg Tab; Drug: Ibuprofen 600 mg tab

Non Narcotic

EXPERIMENTAL

Ibuprofen 600mg Tab + acetaminophen 500 mg Tab

Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab

Interventions

Hydrocodone 5Mg/Acetaminophen 500Mg Tab DRUG

tablet

Also known as: oxycodone

Non Narcotic

Acetaminophen 500Mg Tab DRUG

tablet

Also known as: tylenol

Narcotic

Ibuprofen 600 mg tab DRUG

tablet

Also known as: advil

Narcotic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Joseph Health Care

London, Ontario, N6A 4L6, Canada

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Agnosia

Interventions

Hydrocodone; Acetaminophen; Oxycodone; Ibuprofen

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Joy C MacDermid, PhD

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy C MacDermid, PhD

CONTACT

519-646-6100; jmacderm@uwo.ca

Katrina Munro, CRA

CONTACT

519-646-6100; katrina.munro@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture pain

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: December 18, 2017
• Study Start: August 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)