Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Pain, Acute
• Intervention / Treatment: Drug: Methoxyflurane

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Michael A Austin, MD; Phone Number: 613 737-7228; Email: maustin@toh.ca
• Study Contact Backup: Name: Juiie Sinclair; Phone Number: 613-737-7228; Email: jusinclair@rppeo.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1E2
      • Dr Michael A Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Methoxyflurane; Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4; Other Names: Penthrox; Penthrane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes	Degree of change	For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)	If other medication are used to control pain	For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
Transport time	Defined by departure from scene to arrival at hospital	For length of study, up to 100 patients, specifically departure scene to arrival at hospital
Time to first administration of methoxyflurane	Time from first patient contact to first inhalation of methoxyflurane	For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
Vital signs and level of consciousness	Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))	From patient contact to transfer of care
Adverse events post administration of methoxyflurane:	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).	For length of study, up to 100 patients. Specifically from patient contact to transfer of care

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ambulance; prehospital; methoxyflurane; Penthrox; paramedic; Penthrane
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Methoxyflurane
• Other Study ID Numbers: 20191107100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data for primary and secondary outcome maybe available to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No