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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125811
Acronym
VOMIITED
Enrollment
121
Registered
2017-04-24
Start date
2017-07-17
Completion date
2023-03-01
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

Isopropyl alcohol, Zofran, antiemetics

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.

Interventions

DRUGOral Dissolvable Tablet Zofran (ondansetron)

Single dose 4 mg tablet at 0 minutes.

OTHERInhaled 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.

Sponsors

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nausea Severity60 minutesPatient'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

MeasureTime frameDescription
Emesis Event60 minutesTotal number of emesis will be recorded for the 60 minute participation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026