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Completed

NCT Number: NCT03125811

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Texas Tech University Health Sciences Center El Paso, El Paso, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Isopropyl Alcohol (IPA)

Other

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.

Other names: IPA, alcohol prep pad

Oral Dissolvable Tablet Zofran (ondansetron)

Drug

Single dose 4 mg tablet at 0 minutes.

Other names: OZ

Primary outcomes

  1. Change in Nausea Severity

    Time frame: 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 outcomes

  1. Emesis Event

    Time frame: 60 minutes

    Total number of emesis will be recorded for the 60 minute participation.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Acronym: VOMIITED

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2017
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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