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Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02760069
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Michael D. April, Brooke Army Medical Center

Brief Summary:
This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.

Condition or disease Intervention/treatment Phase
Nausea Drug: Inhaled isopropyl alcohol Drug: Oral ondansetron Drug: Inhaled normal saline Drug: Oral placebo Phase 4

Detailed Description:

This study is a prospective randomized controlled trial to test the hypothesis that nasally-inhaled isopropyl alcohol (ISO) plus oral placebo has greater anti-emetic efficacy compared to oral ondansetron oral solution. By design, the study will be double-blinded insofar as neither investigators nor subjects will be notified of the identity of the substances they are inhaling or swallowing. The study will include a post-study survey to ascertain the extent to which blinding was achieved. Potential subjects are those presenting to the Emergency Department (ED) with nausea and/or vomiting. Investigators will recruit a convenience sample by approaching subjects at the time of initial triage and solicit nausea on a verbal numerical rating scale (VNRS) scored from 0-10 with those patients reporting scores of 3 or greater eligible for study. Informed consent will be obtained from each subject.

Subjects will be allocated to one of three arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron. No subject will receive both inhaled and oral placebo; all subjects will be allocated to at least one therapeutic intervention for nausea. Both investigators and study subjects will be blinded to subject allocation.

Regarding the interventions, upon recruitment, patients will be administered an oral solution (placebo or ondansetron) by their treating nurse. A study team member will then instruct the subject to inhale one of the blinded prep pads, to hold the pad approximately 1 centimeter from their nares, and to take deep nasal inhalations as needed for nausea relief. The investigator will remain at arm's length from the patient at all times to avoid detecting prep pad scent. Additionally, investigators will also instruct subjects to avoid any behavior or actions during the study that would indicate which preparation pad is being used.

The investigators will record their findings on data collection forms. The primary outcome will be nausea as measured on a 10 cm visual analogue scale (VAS) at 30 minutes. Nausea measurements will also be collected at 10, 20, 40, 50, and 60 minutes, and then every hour up to 5 hours, then at disposition at which time the patient will provide one final nausea VAS score. The study team member will not be present in the patient's room during the intervals between these evaluations. At the time of each nausea measurement, patients will be offered another preparation pad (up to ten pads). Investigators will notify the patient's treating provider to prompt consideration for treatment with a rescue anti-emetic (such as metoclopramide or promethazine) if the patient vomits or if the patient requests an anti-emetic at any time. At the time of each nausea measurement, a pain score will also be measured on a 10 cm VAS. At the time of final disposition, the patient will provide a satisfaction score on a 10-cm VAS and be asked to indicate his/her belief as to whether the pad was a treatment or placebo and whether the oral solution was a treatment or placebo. Similarly, at study conclusion the patient's provider will be asked to indicate his/her belief as to whether the pad was a treatment or placebo and whether the oral solution was a treatment or placebo. Other data collected will include times and doses for all medications (including preparation pads) and fluids administered, episodes of vomiting (defined as forceful expulsion of gastric contents separated by at least 2 minutes), disposition (admission versus discharge), final clinical impression at the time of disposition, and time to disposition. Subjects will be followed and data collected for the entirety of their ED stay.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nasally Inhaled Isopropyl Alcohol Versus Oral Ondansetron for the Treatment of Nausea in the Emergency Department: A Double-Blind Randomized Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inhaled ISO + oral ondansetron
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Drug: Inhaled isopropyl alcohol
Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Other Name: ISO

Drug: Oral ondansetron
Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Other Name: Ondansetron

Experimental: Inhaled ISO + oral placebo
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Drug: Inhaled isopropyl alcohol
Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Other Name: ISO

Drug: Oral placebo
Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
Other Name: Oral sugar water

Active Comparator: Inhaled placebo + oral ondansetron
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Drug: Oral ondansetron
Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Other Name: Ondansetron

Drug: Inhaled normal saline
Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
Other Name: Inhaled placebo




Primary Outcome Measures :
  1. Nausea measured by patient written mark on 10 cm visual analogue scale (VAS) [ Time Frame: 30 minutes post intervention ]
    Mark on 10 cm line ranging from "no nausea" on left to "worst nausea imaginable" on right (continuous variable)


Secondary Outcome Measures :
  1. Receipt of rescue anti-emetics measured by nursing drug administration record [ Time Frame: Study duration (up to 5 hours post intervention) ]
    Whether patient required rescue anti-emetics (binary variable)

  2. Patient satisfaction measured by patient written mark on 10 cm visual analogue scale [ Time Frame: Study end (up to 5 hours post intervention) ]
    Mark on 10 cm line ranging from "completely unsatisfied" on left to "completely satisfied" on right (continuous variable)

  3. Time to disposition measured by physician medical record entry [ Time Frame: Study duration (up to 5 hours post intervention) ]
    Time in minutes to provider decisions regarding patient disposition (continuous variable)

  4. Patient vomiting determined by researcher observation [ Time Frame: Study duration (up to 5 hour post intervention) ]
    Whether patient vomiting during Emergency Department stay (binary variable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages 18 and older
  • complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating scale at the time of triage

Exclusion Criteria:

  • allergy to isopropyl alcohol or ondansetron
  • inability to breathe through nose (e.g., recent upper respiratory infection)
  • intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours
  • mental status precluding informed consent including intoxication
  • known QT-prolongation
  • clinical suspicion for serotonin syndrome
  • intravenous catheter in place prior to study start
  • medications administered since patient arrival (e.g., in triage)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760069


Locations
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United States, Texas
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Michael D April, MD, PhD, MSc Brooke Army Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael D. April, Assistant Program Director for Research, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02760069     History of Changes
Other Study ID Numbers: C.2016.091
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Emergencies
Nausea
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Ethanol
Ondansetron
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents