Viewing Study NCT04287803


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Study NCT ID: NCT04287803
Status: COMPLETED
Last Update Posted: 2023-02-28
First Post: 2019-12-02
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
Sponsor: Ottawa Hospital Research Institute
Organization:

Study Overview

Official Title: Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.
Detailed Description: This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient \>= 18 years of age with traumatic pain with a verbal score \>= to 4 will be enrolled.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: