Distal Radius FracturePhase 4NCT03375593
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures
A Phase 4 study testing Hydrocodone 5Mg/Acetaminophen 500Mg Tab, Acetaminophen 500Mg Tab and Ibuprofen 600 mg tab in people with Distal Radius Fracture and Pain Management, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Distal Radius Fracture, Pain Management, Metacarpal Fracture
- What is being tested?
- Hydrocodone 5Mg/Acetaminophen 500Mg Tab, Acetaminophen 500Mg Tab and Ibuprofen 600 mg tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 1 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph Health Care
London, Ontario, N6A 4L6
About this study
Official title: 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
Read the 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
- Being tested
- Hydrocodone 5Mg/Acetaminophen 500Mg Tab, Acetaminophen 500Mg Tab, Ibuprofen 600 mg tab
- Keywords
- pain management, RCT
- Medical subject headings
- Wrist Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone 5Mg/Acetaminophen 500Mg TabDrug
Also called oxycodone
tablet
Acetaminophen 500Mg TabDrug
Also called tylenol
tablet
Ibuprofen 600 mg tabDrug
Also called advil
tablet
| Study group | Role | What they receive |
|---|---|---|
| Narcotic | Experimental | Hydrocodone 5mg/Acetaminophen 500 mg Tab Receives: Drug: Acetaminophen 500Mg Tab; Drug: Ibuprofen 600 mg tab |
| Non Narcotic | Experimental | Ibuprofen 600mg Tab + acetaminophen 500 mg Tab Receives: Drug: Hydrocodone 5Mg/Acetaminophen 500Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-2 weeks
Secondary outcomes (12)
Drug use
Total medication used will be recorded by a pain diary (for the first 2 weeks)
Measured: 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
Measured: 2 weeks
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Measured: 12 weeks
Grip strength
Grip strength in kg will be measured with calibrated instrument and standardized test positioning.
Measured: 24 weeks
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Measured: 12 weeks
Pinch strength
pinch strength in kg will be measured with calibrated instrument and standardized test positioning.
Measured: 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.
Measured: 12 and 24 weeks
Range of Motion
active range of motion will be measured in degrees with standardized test positioning.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Aug 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Joy C MacDermid, PhD, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375593
- Sponsor's protocol ID
- REB 1090503
- Status last verified
- Feb 2021
- First submitted
- 5 Sep 2017
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only de-identified data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03375593
- Acronym / sponsor ID
- REB 1090503
- Conditions
- Distal Radius Fracture, Pain Management, Metacarpal Fracture
- Keywords
- pain management, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Narcotic | Experimental | Drug: Acetaminophen 500Mg Tab, Drug: Ibuprofen 600 mg tabHydrocodone 5mg/Acetaminophen 500 mg Tab |
| Non Narcotic | Experimental | Drug: Hydrocodone 5Mg/Acetaminophen 500Mg TabIbuprofen 600mg Tab + acetaminophen 500 mg Tab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocodone 5Mg/Acetaminophen 500Mg TabAlso: oxycodonetablet | Drug | Non Narcotic |
| Acetaminophen 500Mg TabAlso: tylenoltablet | Drug | Narcotic |
| Ibuprofen 600 mg tabAlso: adviltablet | Drug | Narcotic |
Primary outcome
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
12 secondary outcomes
Drug use
Time frame: 2 weeks
Pain diary
Time frame: 2 weeks
Grip strength
Time frame: 12 weeks
Grip strength
Time frame: 24 weeks
Pinch strength
Time frame: 12 weeks
Pinch strength
Time frame: 24 weeks
Dexterity
Time frame: 12 and 24 weeks
Range of Motion
Time frame: 12 and 24 weeks
pain management
Time frame: 3 weeks
Work Impact
Time frame: 12 and 24 weeks
Future preference
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No. only de-identified data will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy C MacDermid, PhD principal investigator
St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocodone 5Mg/Acetaminophen 500Mg Tab, Acetaminophen 500Mg Tab and Ibuprofen 600 mg tab in people with Distal Radius Fracture and Pain Management, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joy C MacDermid, PhD (519-646-6100 ext. 64636, jmacderm@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 0-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.