MethOxyflUraNe at moderaTe High AltItudes for PAIN Management (MOUNTAIN-PAIN)

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

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

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: Methoxyflurane; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town Department of Anaesthesia & Perioperative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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®).	Drug: Methoxyflurane; Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.; Other Names: Penthrox; Penthrop
Sham Comparator: 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	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.; Other Names: Sham methoxyflurane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: Ross Hofmeyr, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: altitude; analgesia; methoxyflurane; wilderness medicine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Methoxyflurane
• Other Study ID Numbers: MOUNTAIN-PAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No