Clinical trial NCT04287803: Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
Official title: Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Trauma
Keywords: prehospital
paramedic
ambulance
methoxyflurane
Penthrox
Penthrane
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2020-02-27
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to ethics approval for single site
timeFrame: from ethics submission up to 90 days
measure: Time to readiness to initiate the clinical trial
timeFrame: From ethics approval up to 90 days
measure: Evaluation of outcome data collected
timeFrame: For length of study, up to 100 patients
measure: Study protocol compliance by paramedics
timeFrame: For length of study, up to 100 patients
Secondary outcomes:
measure: Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes
timeFrame: For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
measure: Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)
timeFrame: For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
measure: Transport time
timeFrame: For length of study, up to 100 patients, specifically departure scene to arrival at hospital
measure: Time to first administration of methoxyflurane
timeFrame: For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
measure: Vital signs and level of consciousness
timeFrame: From patient contact to transfer of care
measure: Adverse events post administration of methoxyflurane:
timeFrame: For length of study, up to 100 patients. Specifically from patient contact to transfer of care
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Dr Michael A Austin
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Michael A Austin, MD
role: PRINCIPAL_INVESTIGATOR
References: