Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

Nausea Clinical Trial

— VOMIITED  

Official title:

Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125811
• Other study ID #: E17005
• Status: Completed
• Phase: Early Phase 1
• Start date: July 17, 2017
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2023
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Emergency physicians commonly use medications to alleviate nausea and vomiting. The medication Ondansetron is used in the emergency department and after surgery for this purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical trial. The author proposes to prospectively investigate extension of the established antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department patients to the 30-minute post-intervention point that has been reported to be the frequent juncture of symptom relief. By introducing prolonged intervention, and re-dosing of established benefit, into this research, the author aims to reproduce the sustained antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated for post-operative nausea and vomiting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Emergencies
• Nausea
• Vomiting

Intervention

Other:
• Inhaled Isopropyl Alcohol (IPA)
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.

Drug:
• Oral Dissolvable Tablet Zofran (ondansetron)
Single dose 4 mg tablet at 0 minutes.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center El Paso	El Paso	Texas
United States	University Medical Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emesis Event	Total number of emesis will be recorded for the 60 minute participation.	60 minutes