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Clinical Trials/NCT05372133
NCT05372133
Completed
Not Applicable

PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)

The Hospital for Sick Children1 site in 1 country175 target enrollmentAugust 11, 2022
InterventionsMorphine

Overview

Phase
Not Applicable
Intervention
Morphine
Conditions
Pain, Postoperative
Sponsor
The Hospital for Sick Children
Enrollment
175
Locations
1
Primary Endpoint
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study is designed to test the hypothesis that increased electronic order-set compliance and focused education will decrease the amount of unconsumed opioid entering and remaining in the home after pediatric supracondylar fracture repair

The proposed study will address the hypothesis with the following objectives:

  1. investigators will increase compliance with previously implemented standardized precision-based electronic discharge order sets;
  2. investigators will introduce part-fill opioid prescriptions for supracondylar fracture repairs;
  3. investigators will increase parental compliance with home administration of simple (non-opioid) analgesics;
  4. investigators will decrease opioid amount remaining in the home pre and post 3-week follow up.

Detailed Description

Canada has one of the highest opioid prescribing rates in the world (United Nations, 2018). In 2017, Health Quality Ontario published a major report that identified the number of opioid prescriptions following surgery were second only to those following dentist office visits. As a result, Health Quality Ontario made the reduction of opioid prescribing ('Cut the Count)' their number one provincial healthcare priority of 2019. To date, investigators have decreased MME amount of opioid entering the home post-supracondylar fracture repair at approximately 10 MME per patient and increased the rate of return of unused drug by 10 MME per patient. The Hospital for Sick Children alone performs some 200 such surgeries per year, representing 4,000 mg of morphine (four grams) that the community is no longer exposed to. This is only one surgery type in one hospital; expansion of our methodology to other surgeries (currently expanding to dental and cleft palates) and other institutions will dramatically decrease unintentional but iatrogenic home exposure of children and families to unwarranted and dangerous drugs. This latest study aims to address all three steps outlined in the 2020-2021 Health Quality Ontario surgical mandate for children discharged from The Hospital for Sick Children after supracondylar fracture repair.

Registry
clinicaltrials.gov
Start Date
August 11, 2022
End Date
August 18, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Conor McDonnell

Principal Investigator, Associate Professor

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • Patients with Type II or Type III supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.

Exclusion Criteria

  • Patients who are not prescribed morphine following a supracondylar fracture repair surgery

Arms & Interventions

Split Script

Participants will receive four doses initially, with opportunity to obtain four additional doses if required

Intervention: Morphine

Outcomes

Primary Outcomes

Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023

Time Frame: 3 days following discharge from hospital

Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery

Secondary Outcomes

  • Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023(3 weeks following discharge (aligns with pin/wire removal at fracture clinic))
  • Healthcare provider compliance to discharge order set(Up to 100 weeks)
  • Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023(3 days following discharge from hospital)

Study Sites (1)

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