EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron
|ClinicalTrials.gov Identifier: NCT02618343|
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : April 2, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: ISOPROPYL ALCOHOL AROMATHERAPY
Prehospital patients complaining of nausea randomized into the IPA Arm.
IPA Aromatherapy for the experimental arm
Other Name: rubbing alcohol
Active Comparator: Ondansetron
Prehospital patients complaining of nausea randomized into the ondansetron arm.
Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.
Other Name: Zofran
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618343
|United States, Texas|
|San Antonio Fire Department EMS Division|
|San Antonio, Texas, United States, 78207|