Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

December 16, 2021 updated by: Conor McDonnell, The Hospital for Sick Children

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:

  1. 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
  2. This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
  3. There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community

Study Overview

Status

Completed

Conditions

Detailed Description

This study focuses on addressing and minimizing pediatric surgical over-prescribing. It aims to reduce the amount of opioids prescribed by focusing prescribers and families on regular use of simple non-opioid analgesics, as well as decreasing the amount of opioids prescribed and dispensed.

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any child (0-18 years) who has undergone a supracondylar fracture repair at The Hospital for Sick Children.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Conor Mc Donnell, Staff Anesthesiologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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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