MethOxyflUraNe at moderaTe High AltItudes for PAIN Management
NCT ID: NCT03849027
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2019-05-31
2019-12-31
Brief Summary
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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
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Detailed Description
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Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Methoxyflurane
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®).
Methoxyflurane
Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.
Sham Methoxyflurane
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
Placebo
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.
Interventions
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Methoxyflurane
Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent and comply with study-related procedures
Exclusion Criteria
2. Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
3. Chronic or nociplastic pain
4. Chronic fatigue syndrome
5. Chronic/regular use of analgesic medications
6. Personal or familial history of malignant hyperthermia
7. Personal or familial history of anaesthesia-induced rhabdomyolysis
8. Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury
9. Recent volatile anaesthesia (within 6 months)
10. History of significant altitude-related illness
11. Significant underlying medical condition which precludes gentle exercise at moderate high altitude (\<2500 m ASL) as determined by the investigators
12. Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic.
13. Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid)
14. Pregnancy
18 Years
65 Years
ALL
Yes
Sponsors
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University of Cape Town
OTHER
Responsible Party
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Ross Hofmeyr
Prof
Principal Investigators
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Ross Hofmeyr
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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University of Cape Town Department of Anaesthesia & Perioperative Medicine
Cape Town, Western Cape, South Africa
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MOUNTAIN-PAIN
Identifier Type: -
Identifier Source: org_study_id
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