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EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron

NCT02618343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-03-24

Study results available
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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.

Conditions

Interventions

DRUG

IPA

IPA Aromatherapy for the experimental arm

DRUG

Ondansetron

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

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02618343 on ClinicalTrials.gov