Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

NCT04287803 | Completed Phase 4 DMC

• 1 other identifier: 20191107100
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Trauma

Keywords

prehospital; paramedic; ambulance; methoxyflurane; Penthrox; Penthrane

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

• 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

• Transport time

  For length of study, up to 100 patients, specifically departure 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

• Vital signs and level of consciousness

  From patient contact to transfer of care

Study Arms (1)

intervention Arm

EXPERIMENTAL

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

Interventions

Methoxyflurane DRUG

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

Also known as: Penthrox, Penthrane

intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator

Study Sites (1)

Dr Michael A Austin

Ottawa, Ontario, K1H 1E2, Canada

Location

MeSH Terms

Conditions

Acute Pain; Wounds and Injuries

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Michael A Austin, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: February 27, 2020
• Study Start: April 12, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)