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临床试验/NCT05372133
NCT05372133已完成不适用

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

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2022年8月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Split Script

Experimental

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

干预措施: Morphine (Drug)

结局指标

主要结局

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

时间窗: 3 days following discharge from hospital

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

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Conor McDonnell

Principal Investigator, Associate Professor

The Hospital for Sick Children

研究点 (1)

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