NCT03849027

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Cape Town · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

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

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2019-02-21
• Last updated: 2019-02-21

Locations

1 site across 1 country: South Africa