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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eucalyptus Oil Scent | Placebo Comparator | Eucalyptus oil diluted in mineral oil 1:20 |
|
| Isopropyl Alcohol Vapors | Active Comparator | Isopropyl Alcohol 70% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eucalyptus Oil Scent | Other | Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Severity of Nausea on Nausea Scale | 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. | ½ hour or to the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects associated with interventional substance | Patient written report | ½ hour, but likely less than 2 hours |
| Use of anti-nausea medication/Time to use of anti-nausea medication | Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Rau, MD, PhD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Bob Bové Neuroscience Institute | Scottsdale | Arizona | 85251 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Isopropyl Alcohol Vapors | Other | Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack |
|
| ½ hour or to the end of treatment |
| Time to Clinically Relevant Nausea Change | Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine? | ½ hour or to the end of treatment |
| D009422 | Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |