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

Early Phase 1

Completed

• Conditions: Nausea; Vomiting
• Interventions: Other: Inhaled Isopropyl Alcohol (IPA); Drug: Oral Dissolvable Tablet Zofran (ondansetron)

• Registration Number: NCT03125811
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief 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.

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2017-07-17
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Isopropyl Alcohol (IPA)	Inhaled Isopropyl Alcohol (IPA)	Inhaled Isopropyl Alcohol (alcohol prep pad)
Oral Dissolvable Tablet Zofran (OZ)	Oral Dissolvable Tablet Zofran (ondansetron)	4 mg Oral Dissolvable Tablet Zofran (ondansetron)

Primary Outcome Measures

Name	Time	Method
Change in Nausea Severity	60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Emesis Event	60 minutes	Total number of emesis will be recorded for the 60 minute participation.

Trial Locations

Locations (2)

Texas Tech University Health Sciences Center El Paso; 🇺🇸 El Paso, Texas, United States

University Medical Center; 🇺🇸 El Paso, Texas, United States