Split Scripts for Pediatric Supracondylar Fracture Repairs

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372133
• Other study ID #: 1000079222
• Status: Completed
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: August 18, 2023

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Morphine
Children will be provided with morphine for at-home pain management following supracondylar fracture repair

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	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	Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023	Recording of whether Tylenol and Advil were used at-home following supracondylar fracture repair surgery	3 days following discharge from hospital
Secondary	Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023	Recording of how much morphine was returned to the hospital pharmacy	3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Secondary	Healthcare provider compliance to discharge order set	Recording of how often healthcare providers deviate from the standardized electronic discharge order set	Up to 100 weeks