Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

NCT ID: NCT04287803

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2021-11-01

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.

Conditions

Pain, Acute; Trauma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention Arm

Methoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study)

Group Type: EXPERIMENTAL

Methoxyflurane

Intervention Type: DRUG

Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores \>=4

Interventions

Methoxyflurane

Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores \>=4

Intervention Type: DRUG

Other Intervention Names

Penthrox; Penthrane

Eligibility Criteria

Inclusion Criteria

• >=18 years of age
• Acute pain from traumatic injury
• numeric pain score >=4

Exclusion Criteria

• Allergy or sensitivity to methoxyflurane
• History or family history of malignant hyperthermia
• Pregnant or breast-feeding patients
• Known renal impairment
• Known liver disease
• Methoxyflurane use within previous 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ottawa

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Austin, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Dr Michael A Austin

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20191107100

Identifier Type: -

Identifier Source: org_study_id