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Completed

NCT Number: NCT05372133

Split Scripts for Pediatric Supracondylar Fracture Repairs

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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

Other names: Opioid

Primary outcomes

  1. Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023

    Time frame: 3 days following discharge from hospital

    Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery

Secondary outcomes

  1. Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023

    Time frame: 3 days following discharge from hospital

    Recording of whether Tylenol and Advil were used at-home following supracondylar fracture repair surgery

  2. Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023

    Time frame: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)

    Recording of how much morphine was returned to the hospital pharmacy

  3. Healthcare provider compliance to discharge order set

    Time frame: Up to 100 weeks

    Recording of how often healthcare providers deviate from the standardized electronic discharge order set

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 12, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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