Split Scripts for Pediatric Supracondylar Fracture Repairs

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Split Script; Participants will receive four doses initially, with opportunity to obtain four additional doses if required	Drug: Morphine; Children will be provided with morphine for at-home pain management following supracondylar fracture repair; Other Names: Opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Conor Mc Donnell, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 1000079222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No