Inhalation Intervention for Nausea in the Emergency Department

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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

Study Description

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.

Study Design

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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

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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:

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")

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications:

Burleigh-Flayer HD, Gill MW, Strother DE, Masten LW, McKee RH, Tyler TR, Gardiner T. Isopropanol 13-week vapor inhalation study in rats and mice with neurotoxicity evaluation in rats. Fundam Appl Toxicol. 1994 Oct;23(3):421-8.

Gill MW, Burleigh-Flayer HD, Strother DE, Masten LW, McKee RH, Tyler TR, Gardiner TH. Isopropanol: acute vapor inhalation neurotoxicity study in rats. J Appl Toxicol. 1995 Mar-Apr;15(2):77-84.

Burleigh-Flayer H, Garman R, Neptun D, Bevan C, Gardiner T, Kapp R, Tyler T, Wright G. Isopropanol vapor inhalation oncogenicity study in Fischer 344 rats and CD-1 mice. Fundam Appl Toxicol. 1997 Apr;36(2):95-111.

Cotton JW, Rowell LR, Hood RR, Pellegrini JE. A comparative analysis of isopropyl alcohol and ondansetron in the treatment of postoperative nausea and vomiting from the hospital setting to the home. AANA J. 2007 Feb;75(1):21-6.

Winston AW, Rinehart RS, Riley GP, Vacchiano CA, Pellegrini JE. Comparison of inhaled isopropyl alcohol and intravenous ondansetron for treatment of postoperative nausea. AANA J. 2003 Apr;71(2):127-32.

Pellegrini J, DeLoge J, Bennett J, Kelly J. Comparison of inhalation of isopropyl alcohol vs promethazine in the treatment of postoperative nausea and vomiting (PONV) in patients identified as at high risk for developing PONV. AANA J. 2009 Aug;77(4):293-9.

Wang SM, Hofstadter MB, Kain ZN. An alternative method to alleviate postoperative nausea and vomiting in children. J Clin Anesth. 1999 May;11(3):231-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beadle KL, Helbling AR, Love SL, April MD, Hunter CJ. Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):1-9.e1. doi: 10.1016/j.annemergmed.2015.09.031. Epub 2015 Dec 8.

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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

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