Double Blind Randomized Control Trial of Inhaled Isopropyl Alcohol Vapors Versus Inhaled Eucalyptus Scent for the Treatment of Nausea Associated With Acute Migraine
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- HonorHealth Research Institute
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change of Severity of Nausea on Nausea Scale
概览
简要总结
The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.
详细描述
The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Patients 18 to 65 years old with nausea associated migraines at least twice per month
排除标准
- •Patients \<18 or \>65 years old
- •Patients without a diagnosis of acute migraine
研究组 & 干预措施
Eucalyptus Oil Scent
Eucalyptus oil diluted in mineral oil 1:20
干预措施: Eucalyptus Oil Scent (Other)
Isopropyl Alcohol Vapors
Isopropyl Alcohol 70%
干预措施: Isopropyl Alcohol Vapors (Other)
结局指标
主要结局
Change of Severity of Nausea on Nausea Scale
时间窗: ½ hour or to the end of treatment
Change in Nausea, modified visual analog score from 0-10 with 10 severe nausea with vomiting, 5 moderate nausea, 1 mild nausea and 0 no nausea.
次要结局
- Time to Clinically Relevant Nausea Change(½ hour or to the end of treatment)
- Side effects associated with interventional substance(½ hour, but likely less than 2 hours)
- Use of anti-nausea medication/Time to use of anti-nausea medication(½ hour or to the end of treatment)