Inhalation Intervention for Nausea in the Emergency Department

April 15, 2016 updated by: Michael D. April, Brooke Army Medical Center
Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to investigate if inhaling the scent of a typical medical alcohol prep pad will alleviate nausea as compared to a identically packaged normal saline prep pad for the Emergency Department patient with nausea. The study length will be 10 minutes long. The subjects will take several deep nasal inhalations at the 0, 2, 5 minute marks. Level of nausea will be recorded during these times and at 10 minutes. The investigators will also assess satisfaction of the intervention. As in previous post operative unit studies,the hypothesis is that there will a significant difference in levels of nausea between the alcohol pad group versus the normal saline pad group.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Emergency Department, Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age range of 18-65 years of age
  • complaint of nausea and or vomiting
  • ability to breathe through nose
  • ability to read and write English

Exclusion Criteria:

  • allergy to isopropyl alcohol
  • pregnancy or pregnancy status unknown to subject. Pregnancy test only if part of clinical course.
  • recent upper respiratory infection
  • recent intake of cefoperazone, disulfiram, or metronidazole or any other medications that are known produce nausea when exposed to alcohol.
  • use of antiemetic or psychoactive drug within 24 hours
  • alcohol abuse
  • nicotine within last 4 hrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alcohol prep pad group
isopropyl alcohol prep pad
Other: Alcohol prep pad group
Subjects inhale scent of alcohol pad
Placebo Comparator: Normal Saline prep pad
normal saline prep pad
Other: Normal Saline prep pad
Subjects inhale scent of placebo (normal saline) pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention
Time Frame: 10 minutes post intervention
Primary outcome is nausea and vomiting measured on a scale from 0 ("no nausea") to 10 ("worst nausea imaginable") Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention.
10 minutes post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
Time Frame: 10 minutes post intervention
Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")
10 minutes post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction Measured on a 5-point Likert Scale
Time Frame: 10 minutes post intervention
Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 ("completely unsatisfied") to 5 ("completely satisfied")
10 minutes post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Kenneth L Beadle, MPAS, BS, BAMC
  • Study Director: Curtis J Hunter, M.D., BAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAMC 395266-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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