NCT05372133

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. 1.investigators will increase compliance with previously implemented standardized precision-based electronic discharge order sets;
  2. 2.investigators will introduce part-fill opioid prescriptions for supracondylar fracture repairs;
  3. 3.investigators will increase parental compliance with home administration of simple (non-opioid) analgesics;
  4. 4.investigators will decrease opioid amount remaining in the home pre and post 3-week follow up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

February 15, 2022

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    3 days following discharge from hospital

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

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

  • Healthcare provider compliance to discharge order set

    Up to 100 weeks

Study Arms (1)

Split Script

EXPERIMENTAL

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

Drug: Morphine

Interventions

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

Also known as: Opioid
Split Script

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are not prescribed morphine following a supracondylar fracture repair surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineAnalgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Conor Mc Donnell

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

February 15, 2022

First Posted

May 12, 2022

Study Start

August 11, 2022

Primary Completion

August 18, 2023

Study Completion

August 18, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations