Status:
UNKNOWN
MethOxyflUraNe at moderaTe High AltItudes for PAIN Management
Lead Sponsor:
University of Cape Town
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Male or female between 18 and 65 years of age (inclusive).
- Able to provide informed consent and comply with study-related procedures
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03849027
Start Date
May 1 2019
End Date
December 1 2019
Last Update
February 21 2019
Active Locations (1)
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1
University of Cape Town Department of Anaesthesia & Perioperative Medicine
Cape Town, Western Cape, South Africa, 7925