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Inhalation Intervention for Nausea in the Emergency Department

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol prep pad group
Normal Saline prep pad
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring Nausea, Vomiting, Antiemetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department, Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alcohol prep pad group

Normal Saline prep pad

Arm Description

isopropyl alcohol prep pad

normal saline prep pad

Outcomes

Primary Outcome Measures

Nausea Verbal Numerical Rating Scale (0-10) at 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
Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")

Full Information

First Posted
March 18, 2014
Last Updated
April 15, 2016
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02092441
Brief Title
Inhalation Intervention for Nausea in the Emergency Department
Official Title
Inhalation Intervention for Nausea in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Nausea, Vomiting, Antiemetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol prep pad group
Arm Type
Active Comparator
Arm Description
isopropyl alcohol prep pad
Arm Title
Normal Saline prep pad
Arm Type
Placebo Comparator
Arm Description
normal saline prep pad
Intervention Type
Other
Intervention Name(s)
Alcohol prep pad group
Intervention Description
Subjects inhale scent of alcohol pad
Intervention Type
Other
Intervention Name(s)
Normal Saline prep pad
Intervention Description
Subjects inhale scent of placebo (normal saline) pads
Primary Outcome Measure Information:
Title
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention
Description
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.
Time Frame
10 minutes post intervention
Secondary Outcome Measure Information:
Title
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
Description
Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")
Time Frame
10 minutes post intervention
Other Pre-specified Outcome Measures:
Title
Satisfaction Measured on a 5-point Likert Scale
Description
Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 ("completely unsatisfied") to 5 ("completely satisfied")
Time Frame
10 minutes post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth L Beadle, MPAS, BS
Organizational Affiliation
BAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Curtis J Hunter, M.D.
Organizational Affiliation
BAMC
Official's Role
Study Director
Facility Information:
Facility Name
Emergency Department, Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7835543
Citation
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.
Results Reference
background
PubMed Identifier
7782562
Citation
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.
Results Reference
background
PubMed Identifier
9143479
Citation
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.
Results Reference
background
PubMed Identifier
17304779
Citation
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.
Results Reference
background
PubMed Identifier
12776641
Citation
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.
Results Reference
background
PubMed Identifier
19731848
Citation
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.
Results Reference
background
PubMed Identifier
10434220
Citation
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.
Results Reference
background
PubMed Identifier
26679977
Citation
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.
Results Reference
derived

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Inhalation Intervention for Nausea in the Emergency Department

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