CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
IPA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02618343
NCT02618343N/ACompleted

A Randomized Control Equivalence Study of Emergency Medical Services Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron for Treatment of Pre-hospital Nausea

The University of Texas Health Science Center at San Antonio·interventional·Posted Dec 1, 2015·Updated Mar 24, 2021

In Brief

A clinical study evaluating IPA and Ondansetron for Nausea. Completed, enrolled 51 participants across 1 site.

Detailed Summary

Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment that is often treated with oral or intravenous anti-emetic medications. Research Design/Plan: This will be a randomized equivalence study comparing the reduction in a patient's reported level of nausea after treatment with either Ondansetron or IPA Methods: Patients who report nausea and/or vomiting in the normal evaluation and care of after calling 911 for Emergency Medical Care will be offered enrollment in the study. A short script will be attached to the outside of each study packet providing information about the study and its risks and benefits. Verbal or written (waiver of informed consent will be requested) permission will be obtained to start randomization. If the patient agrees to enroll then the study packet will be opened and utilized. All Advanced Life Support Ambulances in the San Antonio Fire Department will have sealed numbered opaque boxes or envelopes with either: 70% Isopropyl Alcohol swabs or ondansetron. Six Visual Nausea Severity Scoring cards will be provided with a marking pen to record timed nausea levels before and upon arrival to the Emergency Department and 15 minutes after treatment whichever comes first. Clinical Relevance: This treatment has not been studied in the unique environment encountered by Paramedics in the Pre-Hospital setting. If this treatment is found to be effective, it many offer a very simple, extremely inexpensive and non-invasive (basic life support) approach for the treatment of nausea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 1, 2015
Enrollment StartOct 4, 2016
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.6 years ago

Interventions

IPAdrug

IPA Aromatherapy for the experimental arm

Ondansetrondrug

Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.