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Trial record 39 of 73 for:    aromatherapy

EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron

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ClinicalTrials.gov Identifier: NCT02618343
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
David Miramontes, The University of Texas Health Science Center at San Antonio

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.


Condition or disease Intervention/treatment Phase
Nausea Drug: IPA Drug: Ondansetron Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Equivalence Study of Emergency Medical Services Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron for Treatment of Pre-hospital Nausea
Study Start Date : July 2016
Actual Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ISOPROPYL ALCOHOL AROMATHERAPY
Prehospital patients complaining of nausea randomized into the IPA Arm.
Drug: IPA
IPA Aromatherapy for the experimental arm
Other Name: rubbing alcohol

Active Comparator: Ondansetron
Prehospital patients complaining of nausea randomized into the ondansetron arm.
Drug: Ondansetron
Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.
Other Name: Zofran




Primary Outcome Measures :
  1. Time to Nausea reduction by 50% by visual analog scale. [ Time Frame: 10 minutes ]
    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 q 2 minutes after administration for 10 minutes.


Secondary Outcome Measures :
  1. need for rescue ondansetron [ Time Frame: 15 minutes ]
    We will compare the number of times that a subject required ondansetron administration after IPA administration, and the number of time ondansetron repeat dose is required in the control group.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618343


Locations
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United States, Texas
San Antonio Fire Department EMS Division
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

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Responsible Party: David Miramontes, Assistant Professor/Clinical, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02618343     History of Changes
Other Study ID Numbers: 15-859H
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Ethanol
Ondansetron
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents