Clinical trial NCT02092441: Inhalation Intervention for Nausea in the Emergency Department
Official title: Inhalation Intervention for Nausea in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Antiemetic
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2014-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention
timeFrame: 10 minutes post intervention
Secondary outcomes:
measure: Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention
timeFrame: 10 minutes post intervention
Other outcomes:
measure: Satisfaction Measured on a 5-point Likert Scale
timeFrame: 10 minutes post intervention
Locations:
city: Fort Sam Houston
country: United States
facility: Emergency Department, Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC
name: Kenneth L Beadle, MPAS, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: BAMC
name: Curtis J Hunter, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.