Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Phase 4

Completed

• Conditions: Trauma; Pain, Acute
• Interventions: Drug: Methoxyflurane

• Registration Number: NCT04287803
• Lead Sponsor: Ottawa Hospital Research Institute

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 Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Study Start: 2021-04-12
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to ethics approval for single site	from ethics submission up to 90 days	Target: ,\<= 3 months (90 days) from ethics submission
Evaluation of outcome data collected	For length of study, up to 100 patients	Target: 100% of data captured in \>90% cases
Time to readiness to initiate the clinical trial	From ethics approval up to 90 days	Target, \<= 3 months (90 days) from ethics approval
Study protocol compliance by paramedics	For length of study, up to 100 patients	Target, \>= 80%

Secondary Outcome Measures

Name	Time	Method
Transport time	For length of study, up to 100 patients, specifically departure scene to arrival at hospital	Defined by departure from scene to arrival at hospital
Time to first administration of methoxyflurane	For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane	Time from first patient contact to first inhalation of methoxyflurane
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes	For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department	Degree of change
Vital signs and level of consciousness	From patient contact to transfer of care	Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)	For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department	If other medication are used to control pain
Adverse events post administration of methoxyflurane:	For length of study, up to 100 patients. Specifically from patient contact to transfer of care	Example: any advanced airway interventions, oxygen requirement (oxygen saturations \<94%), drop in blood pressure by 40% and/or \<90 systolic, complaints of nausea or vomiting, malignant hyperthermia reaction).

Trial Locations

Locations (1)

Dr Michael A Austin; 🇨🇦 Ottawa, Ontario, Canada