Split Scripts for Pediatric Supracondylar Fracture Repairs
PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
1 other identifier
interventional
175
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2023
CompletedNovember 21, 2023
November 1, 2023
1 year
February 15, 2022
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery
3 days following discharge from hospital
Secondary Outcomes (3)
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
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
Study Arms (1)
Split Script
EXPERIMENTALParticipants will receive four doses initially, with opportunity to obtain four additional doses if required
Interventions
Children will be provided with morphine for at-home pain management following supracondylar fracture repair
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who are not prescribed morphine following a supracondylar fracture repair surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Conor Mc Donnell
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Associate Professor
Study Record Dates
First Submitted
February 15, 2022
First Posted
May 12, 2022
Study Start
August 11, 2022
Primary Completion
August 18, 2023
Study Completion
August 18, 2023
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share