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Split Scripts for Pediatric Supracondylar Fracture Repairs

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Morphine
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Split Script

Arm Description

Participants will receive four doses initially, with opportunity to obtain four additional doses if required

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Healthcare provider compliance to discharge order set
Recording of how often healthcare providers deviate from the standardized electronic discharge order set

Full Information

First Posted
February 15, 2022
Last Updated
August 1, 2023
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT05372133
Brief Title
Split Scripts for Pediatric Supracondylar Fracture Repairs
Official Title
PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: investigators will increase compliance with previously implemented standardized precision-based electronic discharge order sets; investigators will introduce part-fill opioid prescriptions for supracondylar fracture repairs; investigators will increase parental compliance with home administration of simple (non-opioid) analgesics; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Split Script
Arm Type
Experimental
Arm Description
Participants will receive four doses initially, with opportunity to obtain four additional doses if required
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Opioid
Intervention Description
Children will be provided with morphine for at-home pain management following supracondylar fracture repair
Primary Outcome Measure Information:
Title
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
Description
Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery
Time Frame
3 days following discharge from hospital
Secondary Outcome Measure Information:
Title
Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023
Description
Recording of whether Tylenol and Advil were used at-home following supracondylar fracture repair surgery
Time Frame
3 days following discharge from hospital
Title
Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023
Description
Recording of how much morphine was returned to the hospital pharmacy
Time Frame
3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Title
Healthcare provider compliance to discharge order set
Description
Recording of how often healthcare providers deviate from the standardized electronic discharge order set
Time Frame
Up to 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conor Mc Donnell
Phone
416-813-7654
Email
conor.mcdonnell@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conor Mc Donnell
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conor Mc Donnell, MD
Phone
416-813-7654
Ext
2687
Email
conor.mcdonnell@sickkids.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Split Scripts for Pediatric Supracondylar Fracture Repairs

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