Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

Pain Management Clinical Trial

Official title:

Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059055
• Other study ID #: 1000064960
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain Management

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain medication use questionnaire	Recording of how many pain meds were used at home	3 days following discharge from hospital
Secondary	Amount of opioid returned	Recording of how much opioid was returned to the hospital	3 weeks following discharge (aligns with pin/wire removal at fracture clinic)