MethOxyflUraNe at moderaTe High AltItudes for PAIN Management: A Randomised, Double-blind, Cross-over Study
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Analgesic effect
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 65 years of age (inclusive).
- •Able to provide informed consent and comply with study-related procedures
排除标准
- •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)
研究组 & 干预措施
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®).
干预措施: Methoxyflurane (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Analgesic effect
时间窗: Up to 3 weeks
Percentage change in analgesic effect between methoxyflurane inhalation at sea level (ALT 0) and 2250m (ALT 2; moderate high altitude).
次要结局
- Safety and adverse events(Up to 3 weeks)
研究者
Ross Hofmeyr
Prof
University of Cape Town