Inhalation Intervention for Nausea in the Emergency Department

Nausea Clinical Trial

Official title:

Inhalation Intervention for Nausea in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092441
• Other study ID #: BAMC 395266-1
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: July 3, 2015
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Other:
• Alcohol prep pad group
Subjects inhale scent of alcohol pad
• Normal Saline prep pad
Subjects inhale scent of placebo (normal saline) pads

Locations

Country	Name	City	State
United States	Emergency Department, Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary Outcome of Satisfaction.	Patient satisfaction of smelling prep pad to alleviate nausea.	2 minute, 5 minute, and 10 minute	No
Primary	Significant Change in Level of Nausea at 4 Minutes Post Intervention	Primary outcome is significant change of nausea and vomiting is defined decrease of 3 on a 0-10 Verbal Numerical Response Scale (VNRS) compared with initial score prior to intervention.	4 minutes post intervention	No
Secondary	Time to Effect for Significant Change in Nausea Level	Secondary outcomes are time to effect, and satisfaction of intervention.	Initial assessment, 2 minute, 5 minute, and 10 minute	No