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MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

NCT03849027 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Ross Hofmeyr · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • South Africa

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849027 on ClinicalTrials.gov