Inhalation Intervention for Nausea in the Emergency Department

NCT02092441 | Completed Results DMC

• 1 other identifier: BAMC 395266-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nausea; Vomiting

Keywords

Nausea; Vomiting; Antiemetic

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes post intervention

Secondary Outcomes (1)

• Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention

  10 minutes post intervention

Other Outcomes (1)

• Satisfaction Measured on a 5-point Likert Scale

  10 minutes post intervention

Study Arms (2)

Alcohol prep pad group

ACTIVE COMPARATOR

isopropyl alcohol prep pad

Other: Alcohol prep pad group

Normal Saline prep pad

PLACEBO COMPARATOR

normal saline prep pad

Other: Normal Saline prep pad

Interventions

Alcohol prep pad group OTHER

Subjects inhale scent of alcohol pad

Alcohol prep pad group

Normal Saline prep pad OTHER

Subjects inhale scent of placebo (normal saline) pads

Normal Saline prep pad

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Emergency Department, Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (8)

• 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.

  PMID: 7835543 BACKGROUND

• 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.

  PMID: 7782562 BACKGROUND

• 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.

  PMID: 9143479 BACKGROUND

• 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.

  PMID: 17304779 BACKGROUND

• 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.

  PMID: 12776641 BACKGROUND

• 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.

  PMID: 19731848 BACKGROUND

• 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.

  PMID: 10434220 BACKGROUND

• 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.

  PMID: 26679977 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Michael D. April
• Organization: Brooke Army Medical Center

Michael.D.April@post.harvard.edu

210-916-6129

Study Officials

• Kenneth L Beadle, MPAS, BS

  BAMC

  PRINCIPAL INVESTIGATOR

• Curtis J Hunter, M.D.

  BAMC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency Associate Program Director for Research

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 23, 2016
• Results First Posted: July 31, 2015

Record last verified: 2016-04

Locations

US (1)