Clinical trial NCT05372133: Split Scripts for Pediatric Supracondylar Fracture Repairs
Official title: PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 175
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
timeFrame: 3 days following discharge from hospital
Secondary outcomes:
measure: Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023
timeFrame: 3 days following discharge from hospital
measure: Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023
timeFrame: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
measure: Healthcare provider compliance to discharge order set
timeFrame: Up to 100 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Conor Mc Donnell
role: PRINCIPAL_INVESTIGATOR
References: