Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 1:27 PM
Study NCT ID:
NCT05372133
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Split Scripts for Pediatric Supracondylar Fracture Repairs
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: