NCT03125811

Brief Summary

This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2017

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

5.6 years

First QC Date

April 13, 2017

Last Update Submit

August 28, 2023

Conditions

NauseaVomiting

Keywords

Isopropyl alcoholZofranantiemetics

Outcome Measures

Primary Outcomes (1)

  • Change in Nausea Severity

    Patient's nausea severity will be assessed at three time points by the study personnel using a verbal nausea rating scale over the course 60 minutes. Severity is scored 0-10 (0 = no nausea; 10 = severe nausea). Time points are at 0 minutes, 30 minutes, and 60 minutes.

    60 minutes

Secondary Outcomes (1)

  • Emesis Event

    60 minutes

Study Arms (2)

Inhaled Isopropyl Alcohol (IPA)

ACTIVE COMPARATOR

Inhaled Isopropyl Alcohol (alcohol prep pad)

Other: Inhaled Isopropyl Alcohol (IPA)

Oral Dissolvable Tablet Zofran (OZ)

OTHER

4 mg Oral Dissolvable Tablet Zofran (ondansetron)

Drug: Oral Dissolvable Tablet Zofran (ondansetron)

Interventions

Inhaled Isopropyl Alcohol (IPA)OTHER

Three doses within 60 minutes. Doses will occur at 0 minutes, 30 minutes, and 60 minutes. Each dose consists of 3 inhalations of one IPA prep pad. A new prep pad is used at each dose.

Also known as: IPA, alcohol prep pad
Inhaled Isopropyl Alcohol (IPA)
Oral Dissolvable Tablet Zofran (ondansetron)DRUG

Single dose 4 mg tablet at 0 minutes.

Also known as: OZ
Oral Dissolvable Tablet Zofran (OZ)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-65 years presenting to the emergency department complaining of current nausea with or without episodes of emesis beginning within the previous 24hrs

You may not qualify if:

  • Patients with known allergy to isopropyl alcohol
  • Patients outside of the defined age range
  • Patients with an inability to inhale through the nares (including recent upper respiratory infection)
  • Patients greater than 20 weeks estimated gestation
  • Patients with past medical history of gastroparesis, or hemoptysis
  • Patients who have taken an antiemetic medication in the past 48 hours
  • Patients demonstrating hemodynamic instability with systolic blood pressure \<90 or tachycardia \>120 bpm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

University Medical Center

El Paso, Texas, 79905, United States

Location

Related Publications (11)

  • Myer PA, Mannalithara A, Singh G, Singh G, Pasricha PJ, Ladabaum U. Clinical and economic burden of emergency department visits due to gastrointestinal diseases in the United States. Am J Gastroenterol. 2013 Sep;108(9):1496-507. doi: 10.1038/ajg.2013.199. Epub 2013 Jul 16.

    PMID: 23857475BACKGROUND

  • Braude D, Soliz T, Crandall C, Hendey G, Andrews J, Weichenthal L. Antiemetics in the ED: a randomized controlled trial comparing 3 common agents. Am J Emerg Med. 2006 Mar;24(2):177-82. doi: 10.1016/j.ajem.2005.08.017.

    PMID: 16490647BACKGROUND

  • Patanwala AE, Amini R, Hays DP, Rosen P. Antiemetic therapy for nausea and vomiting in the emergency department. J Emerg Med. 2010 Sep;39(3):330-6. doi: 10.1016/j.jemermed.2009.08.060. Epub 2009 Dec 21.

    PMID: 20022195BACKGROUND

  • Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.

    PMID: 20825792BACKGROUND

  • Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.

    PMID: 26411330BACKGROUND

  • Ohashi Y, Nakai Y, Ikeoka H, Koshimo H, Esaki Y, Horiguchi S, Teramoto K, Nakaseko H. An experimental study on the respiratory toxicity of isopropyl alcohol. J Appl Toxicol. 1988 Feb;8(1):67-71. doi: 10.1002/jat.2550080111.

    PMID: 3356866BACKGROUND

  • 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: 7782562BACKGROUND

  • 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: 12776641BACKGROUND

  • 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: 19731848BACKGROUND

  • Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007598. doi: 10.1002/14651858.CD007598.pub2.

    PMID: 22513952BACKGROUND

  • 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: 26679977BACKGROUND

MeSH Terms

Conditions

NauseaVomiting

Interventions

EthanolOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Scott Crawford, MD

    Texas Tech Universtiy Health Sciences Center El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 24, 2017

Study Start

July 17, 2017

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

US(2)