Skip to main content
OpenTrials
Completed

NCT Number: NCT04287803

Prehospital Analgesia in Adults Using Inhaled 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr Michael A Austin

Ottawa, Ontario, K1H 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methoxyflurane

Drug

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

Other names: Penthrox, Penthrane

Primary outcomes

  1. Time to ethics approval for single site

    Time frame: from ethics submission up to 90 days

    Target: ,<= 3 months (90 days) from ethics submission

  2. Time to readiness to initiate the clinical trial

    Time frame: From ethics approval up to 90 days

    Target, <= 3 months (90 days) from ethics approval

  3. Evaluation of outcome data collected

    Time frame: For length of study, up to 100 patients

    Target: 100% of data captured in >90% cases

  4. Study protocol compliance by paramedics

    Time frame: For length of study, up to 100 patients

    Target, >= 80%

Secondary outcomes

  1. Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes

    Time frame: For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department

    Degree of change

  2. Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)

    Time frame: 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

  3. Transport time

    Time frame: For length of study, up to 100 patients, specifically departure scene to arrival at hospital

    Defined by departure from scene to arrival at hospital

  4. Time to first administration of methoxyflurane

    Time frame: 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

  5. Vital signs and level of consciousness

    Time frame: From patient contact to transfer of care

    Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))

  6. Adverse events post administration of methoxyflurane:

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.