MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03849027

Acronym

MOUNTAIN-PAIN

Enrollment

Registered

2019-02-21

Start date

2019-05-31

Completion date

2019-12-31

Last updated

2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

altitude, analgesia, methoxyflurane, wilderness medicine

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 clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers

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 with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Interventions

DRUGMethoxyflurane

Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

double-blind

Intervention model description

randomised, controlled, cross-over

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male or female between 18 and 65 years of age (inclusive). 2. Able to provide informed consent and comply with study-related procedures

Exclusion criteria

1. History of diabetes 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

Design outcomes

Primary

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

Secondary

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

Countries

South Africa

Contacts

Primary ContactRoss Hofmeyr

ross.hofmeyr@uct.ac.za+2721 650 4957

Backup ContactNicky Kramer

nicky.kramer@uct.ac.za+2721 650 4196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026