Trial Outcomes & Findings for EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron (NCT NCT02618343)

Last Updated: 2021-03-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Baseline and up to 10 minutes

Results posted on

2021-03-24

Participant Flow

Patients being transported to the hospital by EMS will be recruited

Participant milestones

Participant milestones
Measure	Isopropyl Alcohol Prehospital nausea patient randomized into the IPA group	Ondansetron Group Prehospital nausea patient randomized to the Ondansetron group
Overall Study STARTED	28	23
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ISOPROPYL ALCOHOL AROMATHERAPY n=28 Participants Prehospital patients complaining of nausea randomized into the IPA Arm. IPA: IPA Aromatherapy for the experimental arm	Ondansetron n=23 Participants Prehospital patients complaining of nausea randomized into the ondansetron arm. Ondansetron: Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.	Total n=51 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Nausea level	4.3 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 2.9 • n=7 Participants	4.0 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 10 minutes

Outcome measures

Outcome measures
Measure	Isopropyl Alcohol n=28 Participants Prehospital nausea patient randomized into the IPA group	Ondansetron Group n=23 Participants Prehospital nausea patient randomized to the Ondansetron group
Time to Nausea Reduction by 50% by Visual Analog Scale.	4.3 Minutes Standard Deviation 3.1	3.5 Minutes Standard Deviation 2.9

SECONDARY outcome

Timeframe: 15 minutes

Population: EMS Patients

We will compare the number of times that a subject required ondansetron administration after IPA administration, and the number of times ondansetron repeat dose is required in the control group.

Outcome measures

Outcome measures
Measure	Isopropyl Alcohol n=23 Participants Prehospital nausea patient randomized into the IPA group	Ondansetron Group n=28 Participants Prehospital nausea patient randomized to the Ondansetron group
Number of Subjects That Required Rescue Ondansetron	0 Participants	2 Participants

Adverse Events

Isopropyl Alcohol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ondansetron Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Wampler, PhD, LP

UT Health San Antonio

Phone: 210-414-9548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place