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Completed

NCT Number: NCT02092441

Inhalation Intervention for Nausea in the Emergency Department

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

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Key information

Conditions

Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol prep pad group

Other

Subjects inhale scent of alcohol pad

Normal Saline prep pad

Other

Subjects inhale scent of placebo (normal saline) pads

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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")

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 20, 2014
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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