MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

Study Overview
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Brief Summary
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A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting. Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers

Detailed Description
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Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting. Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Official Title
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MethOxyflUraNe at moderaTe High AltItudes for PAIN Management: A Randomised, Double-blind, Cross-over Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Methoxyflurane
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 and 65 years of age (inclusive). Able to provide informed consent and comply with study-related procedures Exclusion Criteria: History of diabetes Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range) Chronic or nociplastic pain Chronic fatigue syndrome Chronic/regular use of analgesic medications Personal or familial history of malignant hyperthermia Personal or familial history of anaesthesia-induced rhabdomyolysis Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury Recent volatile anaesthesia (within 6 months) History of significant altitude-related illness Significant underlying medical condition which precludes gentle exercise at moderate high altitude (<2500 m ASL) as determined by the investigators Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic. Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomised, controlled, cross-over
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methoxyflurane<br>Inhaled methoxyflurane once-off dose of 3 ml will be administered via the inhaler at each dosing visit . Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®). | Drug: Methoxyflurane<br>* Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.<br>* Other names: Penthrox;|
| Sham Comparator: Sham Methoxyflurane<br>The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test | Drug: Placebo<br>* The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test.<br>* Other names: Sham methoxyflurane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic effect | Percentage change in analgesic effect between methoxyflurane inhalation at sea level (ALT 0) and 2250m (ALT 2; moderate high altitude). | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and adverse events | Comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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altitude, analgesia, methoxyflurane, wilderness medicine