EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron

NCT02618343 | Completed Results

• 1 other identifier: 15-859H
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Nausea

Outcome Measures

Primary Outcomes (1)

• Time to Nausea Reduction by 50% by Visual Analog Scale.

  A visual analog scale (VAS) will be utilized to determine level of nausea. The VAS scale will be utilized before enrollment, at the time of medication administration, then every 2 minutes after administration for 10 minutes. The scale is a numbered linear scale from 0-10, with 0 = no nausea and 10 = worst nausea possible

  Baseline and up to 10 minutes

Secondary Outcomes (1)

• Number of Subjects That Required Rescue Ondansetron

  15 minutes

Study Arms (2)

ISOPROPYL ALCOHOL AROMATHERAPY

EXPERIMENTAL

Prehospital patients complaining of nausea randomized into the IPA Arm.

Drug: IPA

Ondansetron

ACTIVE COMPARATOR

Prehospital patients complaining of nausea randomized into the ondansetron arm.

Drug: Ondansetron

Interventions

IPA DRUG

IPA Aromatherapy for the experimental arm

Also known as: rubbing alcohol

ISOPROPYL ALCOHOL AROMATHERAPY

Ondansetron DRUG

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

Also known as: Zofran

Ondansetron

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (non-pregnant) age 18 years or older with a symptom of nausea and/or vomiting requiring treatment by EMS

You may not qualify if:

• Children not yet 18 years of Age
• Prisoners or those under arrest
• Patients known or suspected to be Pregnant
• Clinical Intoxication
• Patients unable to provide informed consent
• Recent Upper respiratory Tract infection
• Inability to follow instructions
• Inability to inhale through Nares

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

San Antonio Fire Department EMS Division

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Nausea

Interventions

2-Propanol; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: David Wampler, PhD, LP
• Organization: UT Health San Antonio

wamplerd@uthscsa.edu

210-414-9548

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: December 1, 2015
• Study Start: October 4, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

US (1)