Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department
NCT02760069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2020-07-23
Summary
This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.
Conditions
Interventions
- DRUG
-
Inhaled isopropyl alcohol
Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
- DRUG
-
Oral ondansetron
Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
- DRUG
-
Inhaled normal saline
Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
- DRUG
-
Oral placebo
Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
Sponsors & Collaborators
-
Brooke Army Medical Center
lead FED
Principal Investigators
-
Michael D April, MD, PhD, MSc · Brooke Army Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2017-11-30
- Completion
- 2017-11-30
Countries
- United States
Study Locations
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