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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375593
• Other study ID #: REB 1090503
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2021
• Source: Lawson Health Research Institute
• Contact: Joy C MacDermid, PhD
• Phone: 519-646-6100
• Email: jmacderm[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Metacarpal Fracture
• Pain Management
• Radius Fractures

Intervention

Drug:
• Hydrocodone 5Mg/Acetaminophen 500Mg Tab
tablet
• Acetaminophen 500Mg Tab
tablet
• Ibuprofen 600 mg tab
tablet

Locations

Country	Name	City	State
Canada	St. Joseph Health Care	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Drug use	Total medication used will be recorded by a pain diary (for the first 2 weeks)	2 weeks
Secondary	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
Secondary	Grip strength	Grip strength in kg will be measured with calibrated instrument and standardized test positioning.	12 weeks
Secondary	Grip strength	Grip strength in kg will be measured with calibrated instrument and standardized test positioning.	24 weeks
Secondary	Pinch strength	pinch strength in kg will be measured with calibrated instrument and standardized test positioning.	12 weeks
Secondary	Pinch strength	pinch strength in kg will be measured with calibrated instrument and standardized test positioning.	24 weeks
Secondary	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
Secondary	Range of Motion	active range of motion will be measured in degrees with standardized test positioning.	12 and 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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