Inhalation Intervention for Nausea in the Emergency Department

Not Applicable

Completed

• Conditions: Vomiting; Nausea
• Interventions: Other: Normal Saline prep pad; Other: Alcohol prep pad group

• Registration Number: NCT02092441
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Study Start: 2014-04
• Primary Completion: 2014-11
• Study Completion: 2015-06
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Results First Posted: 2015-07-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline prep pad	Normal Saline prep pad	normal saline prep pad
Alcohol prep pad group	Alcohol prep pad group	isopropyl alcohol prep pad

Primary Outcome Measures

Name	Time	Method
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention	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

Name	Time	Method
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention	10 minutes post intervention	Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")

Trial Locations

Locations (1)

Emergency Department, Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States