Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Trauma

Intervention / Treatment
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* Drug: Methoxyflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention Arm<br>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<br>* Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4<br>* Other names: Penthrane;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane