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

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ClinicalTrials.gov Identifier: NCT03375593
Recruitment Status : Not yet recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Pain Management Metacarpal Fracture Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab Drug: Acetaminophen 500Mg Tab Drug: Ibuprofen 600 mg tab Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants will be randomized to receive either the narcotic hydrocodone with acetaminophen or a combination of acetaminophen plus ibuprofen for post-fracture pain
Masking: Double (Participant, Investigator)
Masking Description: study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs
Primary Purpose: Treatment
Official Title: Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
Anticipated Study Start Date : February 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Narcotic
Hydrocodone 5mg/Acetaminophen 500 mg Tab
Drug: Acetaminophen 500Mg Tab
Other Name: tylenol
Drug: Ibuprofen 600 mg tab
Other Name: advil
Experimental: Non Narcotic
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab
Other Name: oxycodone

Outcome Measures

Primary Outcome Measures :
  1. Pain [ Time Frame: 0-2 weeks ]

    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

Secondary Outcome Measures :
  1. Drug use [ Time Frame: 2 weeks ]
    Total medication used will be recorded by a pain diary (for the first 2 weeks)

  2. Pain diary [ Time Frame: 2 weeks ]
    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

  3. Grip strength [ Time Frame: 12 weeks ]
    Grip strength in kg will be measured with calibrated instrument and standardized test positioning.

  4. Grip strength [ Time Frame: 24 weeks ]
    Grip strength in kg will be measured with calibrated instrument and standardized test positioning.

  5. Pinch strength [ Time Frame: 12 weeks ]
    pinch strength in kg will be measured with calibrated instrument and standardized test positioning.

  6. Pinch strength [ Time Frame: 24 weeks ]
    pinch strength in kg will be measured with calibrated instrument and standardized test positioning.

  7. Dexterity [ Time Frame: 12 and 24 weeks ]
    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.

  8. Range of Motion [ Time Frame: 12 and 24 weeks ]
    active range of motion will be measured in degrees with standardized test positioning.

  9. pain management [ Time Frame: 3 weeks ]
    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

  10. Work Impact [ Time Frame: 12 and 24 weeks ]
    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)

  11. Future preference [ Time Frame: 24 weeks ]
    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

  12. Adverse events [ Time Frame: 24 weeks ]
    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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375593

Contact: Joy C MacDermid, PhD 519-646-6100 ext 64636 jmacderm@uwo.ca
Contact: Katrina Munro, CRA 519-646-6100 ext 64640 katrina.munro@sjhc.london.on.ca

Canada, Ontario
St. Joseph Health Care
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Joy C MacDermid, PhD St. Joseph's Health Care London
More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03375593     History of Changes
Other Study ID Numbers: REB 1090503
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only de-identified data will be available upon request

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawson Health Research Institute:
pain management

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents