Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

Study Overview
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Brief Summary
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This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.

Detailed Description
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Emergency physicians commonly use medications to alleviate nausea and vomiting. The medication Ondansetron is used in the emergency department and after surgery for this purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical trial. The author proposes to prospectively investigate extension of the established antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department patients to the 30-minute post-intervention point that has been reported to be the frequent juncture of symptom relief. By introducing prolonged intervention, and re-dosing of established benefit, into this research, the author aims to reproduce the sustained antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated for post-operative nausea and vomiting.

Official Title
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Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Other: Inhaled Isopropyl Alcohol (IPA)
* Drug: Oral Dissolvable Tablet Zofran (ondansetron)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-65 years presenting to the emergency department complaining of current nausea with or without episodes of emesis beginning within the previous 24hrs Exclusion Criteria: Patients with known allergy to isopropyl alcohol Patients outside of the defined age range Patients with an inability to inhale through the nares (including recent upper respiratory infection) Patients greater than 20 weeks estimated gestation Patients with past medical history of gastroparesis, or hemoptysis Patients who have taken an antiemetic medication in the past 48 hours Patients demonstrating hemodynamic instability with systolic blood pressure <90 or tachycardia >120 bpm

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inhaled Isopropyl Alcohol (IPA)<br>Inhaled Isopropyl Alcohol (alcohol prep pad) | Other: Inhaled Isopropyl Alcohol (IPA)<br>* Three doses within 60 minutes. Doses will occur at 0 minutes, 30 minutes, and 60 minutes. Each dose consists of 3 inhalations of one IPA prep pad. A new prep pad is used at each dose.<br>* Other names: alcohol prep pad;|
| Other: Oral Dissolvable Tablet Zofran (OZ)<br>4 mg Oral Dissolvable Tablet Zofran (ondansetron) | Drug: Oral Dissolvable Tablet Zofran (ondansetron)<br>* Single dose 4 mg tablet at 0 minutes.<br>* Other names: OZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nausea Severity | Patient's nausea severity will be assessed at three time points by the study personnel using a verbal nausea rating scale over the course 60 minutes. Severity is scored 0-10 (0 = no nausea; 10 = severe nausea). Time points are at 0 minutes, 30 minutes, and 60 minutes. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emesis Event | Total number of emesis will be recorded for the 60 minute participation. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isopropyl alcohol, Zofran, antiemetics