MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

Pain Clinical Trial

— MOUNTAIN-PAIN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03849027
• Other study ID #: MOUNTAIN-PAIN
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2019
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: University of Cape Town
• Contact: Ross Hofmeyr
• Phone: +2721 650 4957
• Email: ross.hofmeyr[@]uct.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Cape Town Department of Anaesthesia & Perioperative Medicine	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

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