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Inhalation Intervention for Nausea in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092441
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : July 31, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Michael D. April, Brooke Army Medical Center

Brief Summary:
Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Other: Alcohol prep pad group Other: Normal Saline prep pad Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Inhalation Intervention for Nausea in the Emergency Department
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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")


Other Outcome Measures:
  1. 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")



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092441


Locations
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United States, Texas
Emergency Department, Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Kenneth L Beadle, MPAS, BS BAMC
Study Director: Curtis J Hunter, M.D. BAMC
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael D. April, Residency Associate Program Director for Research, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02092441    
Other Study ID Numbers: BAMC 395266-1
First Posted: March 20, 2014    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: May 23, 2016
Last Verified: April 2016
Keywords provided by Michael D. April, Brooke Army Medical Center:
Nausea
Vomiting
Antiemetic
Additional relevant MeSH terms:
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Emergencies
Nausea
Vomiting
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive