MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

NCT03849027 | Unknown Phase 4

• 1 other identifier: MOUNTAIN-PAIN
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

altitude; analgesia; methoxyflurane; wilderness medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and adverse events

  Up to 3 weeks

Study Arms (2)

Methoxyflurane

EXPERIMENTAL

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

Sham Methoxyflurane

SHAM COMPARATOR

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

Interventions

Methoxyflurane DRUG

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

Also known as: Penthrop, Penthrox

Methoxyflurane

Placebo DRUG

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.

Also known as: Sham methoxyflurane

Sham Methoxyflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

University of Cape Town Department of Anaesthesia & Perioperative Medicine

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Ross Hofmeyr

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross Hofmeyr

CONTACT

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

Nicky Kramer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: randomised, controlled, cross-over

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

ZA (1)