Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Double Blind Randomized Control Trial of Inhaled Isopropyl Alcohol Vapors Versus Inhaled Eucalyptus Scent for the Treatment of Nausea Associated With Acute Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Other: Eucalyptus Oil Scent
* Other: Isopropyl Alcohol Vapors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 to 65 years old with nausea associated migraines at least twice per month Exclusion Criteria: Patients <18 or >65 years old Patients without a diagnosis of acute migraine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Eucalyptus Oil Scent<br>Eucalyptus oil diluted in mineral oil 1:20 | Other: Eucalyptus Oil Scent<br>* Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack<br>|
| Active Comparator: Isopropyl Alcohol Vapors<br>Isopropyl Alcohol 70% | Other: Isopropyl Alcohol Vapors<br>* Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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? | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Isopropyl alcohol, Eucalyptus, Aromatherapy, Vapors