NCT03125811

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
OTHER	Inhaled Isopropyl Alcohol (IPA)	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.
DRUG	Oral Dissolvable Tablet Zofran (ondansetron)	Single dose 4 mg tablet at 0 minutes.

Timeline

• Start date: 2017-07-17
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2017-04-24
• Last updated: 2023-08-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study