Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

NCT02760069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-07-23

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760069 on ClinicalTrials.gov