Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED) (VOMIITED)
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inhaled Isopropyl Alcohol (IPA)
Oral Dissolvable Tablet Zofran (ondansetron)
Sponsored by
About this trial
This is an interventional supportive care trial for Nausea focused on measuring Isopropyl alcohol, Zofran, antiemetics
Eligibility Criteria
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
Sites / Locations
- Texas Tech University Health Sciences Center El Paso
- University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Inhaled Isopropyl Alcohol (IPA)
Oral Dissolvable Tablet Zofran (OZ)
Arm Description
Inhaled Isopropyl Alcohol (alcohol prep pad)
4 mg Oral Dissolvable Tablet Zofran (ondansetron)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Emesis Event
Total number of emesis will be recorded for the 60 minute participation.
Full Information
NCT ID
NCT03125811
First Posted
April 13, 2017
Last Updated
August 28, 2023
Sponsor
Texas Tech University Health Sciences Center, El Paso
1. Study Identification
Unique Protocol Identification Number
NCT03125811
Brief Title
Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
Acronym
VOMIITED
Official Title
Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Isopropyl alcohol, Zofran, antiemetics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled Isopropyl Alcohol (IPA)
Arm Type
Active Comparator
Arm Description
Inhaled Isopropyl Alcohol (alcohol prep pad)
Arm Title
Oral Dissolvable Tablet Zofran (OZ)
Arm Type
Other
Arm Description
4 mg Oral Dissolvable Tablet Zofran (ondansetron)
Intervention Type
Other
Intervention Name(s)
Inhaled Isopropyl Alcohol (IPA)
Other Intervention Name(s)
IPA, alcohol prep pad
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Dissolvable Tablet Zofran (ondansetron)
Other Intervention Name(s)
OZ
Intervention Description
Single dose 4 mg tablet at 0 minutes.
Primary Outcome Measure Information:
Title
Change in Nausea Severity
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Emesis Event
Description
Total number of emesis will be recorded for the 60 minute participation.
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Crawford, MD
Organizational Affiliation
Texas Tech Universtiy Health Sciences Center El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
University Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23857475
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.
Results Reference
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PubMed Identifier
16490647
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.
Results Reference
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PubMed Identifier
20022195
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.
Results Reference
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PubMed Identifier
20825792
Citation
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.
Results Reference
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PubMed Identifier
26411330
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.
Results Reference
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PubMed Identifier
3356866
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.
Results Reference
background
PubMed Identifier
7782562
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.
Results Reference
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PubMed Identifier
12776641
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.
Results Reference
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PubMed Identifier
19731848
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.
Results Reference
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PubMed Identifier
22513952
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.
Results Reference
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PubMed Identifier
26679977
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.
Results Reference
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Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
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