Inhalation Intervention for Nausea in the Emergency Department

NCT ID: NCT02092441

Last Updated: 2016-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Alcohol prep pad group

isopropyl alcohol prep pad

Group Type ACTIVE_COMPARATOR

Alcohol prep pad group

Intervention Type OTHER

Subjects inhale scent of alcohol pad

Normal Saline prep pad

normal saline prep pad

Group Type PLACEBO_COMPARATOR

Normal Saline prep pad

Intervention Type OTHER

Subjects inhale scent of placebo (normal saline) pads

Interventions

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Alcohol prep pad group

Subjects inhale scent of alcohol pad

Intervention Type OTHER

Normal Saline prep pad

Subjects inhale scent of placebo (normal saline) pads

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Michael D. April

Residency Associate Program Director for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth L Beadle, MPAS, BS

Role: PRINCIPAL_INVESTIGATOR

BAMC

Curtis J Hunter, M.D.

Role: STUDY_DIRECTOR

BAMC

Locations

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Emergency Department, Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1006/faat.1994.1123.

Reference Type BACKGROUND
PMID: 7835543 (View on PubMed)

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. doi: 10.1002/jat.2550150204.

Reference Type BACKGROUND
PMID: 7782562 (View on PubMed)

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. doi: 10.1006/faat.1996.2284.

Reference Type BACKGROUND
PMID: 9143479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17304779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12776641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19731848 (View on PubMed)

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. doi: 10.1016/s0952-8180(99)00035-5.

Reference Type BACKGROUND
PMID: 10434220 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26679977 (View on PubMed)

Other Identifiers

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BAMC 395266-1

Identifier Type: -

Identifier Source: org_study_id

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