MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

Phase 4

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Methoxyflurane

• Registration Number: NCT03849027
• Lead Sponsor: University of Cape Town

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-19
• Last Update Submitted: 2019-02-19
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21
• Study Start: 2019-05
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Methoxyflurane	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
Methoxyflurane	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®).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Cape Town Department of Anaesthesia & Perioperative Medicine; 🇿🇦 Cape Town, Western Cape, South Africa