Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 4

Conditions: Trauma; Pain, Acute

Treatments: Drug: Methoxyflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT04287803

20191107100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

intervention Arm

Experimental group

Description:

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

Treatment:

Drug: Methoxyflurane