Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
NCT ID: NCT03125811
Last Updated: 2023-08-29
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
121 participants
INTERVENTIONAL
2017-07-17
2023-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Inhaled Isopropyl Alcohol (IPA)
Inhaled Isopropyl Alcohol (alcohol prep pad)
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.
Oral Dissolvable Tablet Zofran (OZ)
4 mg Oral Dissolvable Tablet Zofran (ondansetron)
Oral Dissolvable Tablet Zofran (ondansetron)
Single dose 4 mg tablet at 0 minutes.
Interventions
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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.
Oral Dissolvable Tablet Zofran (ondansetron)
Single dose 4 mg tablet at 0 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Texas Tech University Health Sciences Center, El Paso
OTHER
Responsible Party
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Scott Crawford
Associate Professor
Principal Investigators
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Scott Crawford, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech Universtiy Health Sciences Center El Paso
Locations
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Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States
University Medical Center
El Paso, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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E17005
Identifier Type: -
Identifier Source: org_study_id
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