- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059055
Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair
Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up.
The investigators' previous prospective observational deception study identified three areas of concern:
- There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures
- This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
- There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
- Patients discharged on the weekday.
- Families filling a prescription for opioids at Shoppers Drug Mart at SickKids Hospital.
- Parent has strong command of the English language (i.e., no interpreter required).
Exclusion Criteria:
- Patients with a history of chronic pain.
- Patient used opioid medication within the previous 6 months.
- Patients who are discharged on the weekend (as participant emails will need to be entered into redcap the day of recruitment, for data collection to commence the next morning).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain medication use questionnaire
Time Frame: 3 days following discharge from hospital
|
Recording of how many pain meds were used at home
|
3 days following discharge from hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of opioid returned
Time Frame: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
|
Recording of how much opioid was returned to the hospital
|
3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Conor Mc Donnell, Staff Anesthesiologist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1000064960
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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