<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464915</url>
  </required_header>
  <id_info>
    <org_study_id>20190789-01H</org_study_id>
    <nct_id>NCT04464915</nct_id>
  </id_info>
  <brief_title>Isopropyl Alcohol Inhalation as Anti-emetic Therapy in the Emergency Department</brief_title>
  <official_title>Isopropyl Alcohol Inhalation as Anti-emetic Therapy in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nausea and vomiting is a common and distressing presenting complaint in Canadian emergency&#xD;
      departments. Commonly used nausea medications have proven to be effective in certain patient&#xD;
      populations, for example cancer patients. However, not one has been proven to be more&#xD;
      effective that the other in the emergency department setting. In addition, many are&#xD;
      associated with significant side effects and have the potential to interact with a patient's&#xD;
      home medications. This limits their use in the emergency department until the patient is seen&#xD;
      and assessed by their treating physician.&#xD;
&#xD;
      Many studies have shown that nasal inhalation of alcohol swabs is an effective therapy in&#xD;
      relieving nausea and vomiting in post-operative patients after surgeries. The goal of this&#xD;
      study will be to determine the effectiveness of alcohol swabs in the emergency department&#xD;
      setting in relieving nausea and vomiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND INFORMATION:&#xD;
&#xD;
      Emerging evidence exists supporting the use of nasally inhaled isopropyl alcohol swabs as&#xD;
      anti-emetic therapy. Multiple studies report isopropyl alcohol inhalation as an effective&#xD;
      treatment for post-operative nausea and vomiting, with no reported adverse events. This&#xD;
      relatively inexpensive substance is widely available in most health care settings in the form&#xD;
      of swabs used in the routine course of delivering care as an antiseptic skin cleanser. Two&#xD;
      previous studies in the United States have evaluated the use of inhaled isopropyl alcohol&#xD;
      swabs in alleviating nausea and vomiting in the emergency department setting. One study in&#xD;
      2016 study by Beadle et. al. demonstrated superior nausea relief using inhaled isopropyl&#xD;
      alcohol swabs compared to an inhaled placebo, while a 2018 study by April et. al.&#xD;
      demonstrated superior nausea relief with isopropyl alcohol swabs compared with inhaled&#xD;
      placebo and oral ondansetron.&#xD;
&#xD;
      The 2016 study by Beadle et. al. has several important limitations. This was a single center&#xD;
      military hospital study, which only measured nausea scores 10 minutes after isopropyl alcohol&#xD;
      swab inhalation, and lacked other important outcomes such as the number of vomiting episodes,&#xD;
      use of rescue anti-emetics, ED length of stay and admission rates. The 2018 study by April&#xD;
      et. al. also has limitations. Mainly, alcohol swabs were used as often as required by&#xD;
      participants, and the dosing frequency of inhalations was not measured. They also excluded&#xD;
      patients who had a peripheral intravenous catheter inserted on arrival, which could suggest&#xD;
      that patients with more severe symptoms of nausea and vomiting requiring intravenous&#xD;
      anti-emetics were excluded.&#xD;
&#xD;
      STUDY RATIONALE:&#xD;
&#xD;
      The investigator's goal is to add to the current body of evidence on the use of isopropyl&#xD;
      alcohol in alleviating nausea and vomiting in the emergency department, particularly by&#xD;
      determining which dosing frequency of isopropyl alcohol inhalation yields the most effective&#xD;
      nausea relief by randomizing patients to different inhalation frequencies. This may help to&#xD;
      guide future triage protocols enabling isopropyl alcohol inhalation before provider&#xD;
      evaluation to improve treatment of nausea and patient satisfaction. In the current state of&#xD;
      emergency department overcrowding, the ability to adequately control a patient's symptoms at&#xD;
      triage may help decrease a patient's length of stay, as well as the number of patients&#xD;
      requiring beds. In addition, from a cost-savings perspective, alcohol swabs are a relatively&#xD;
      inexpensive therapy as compared to many commonly administered anti-emetics.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      The objective of this study is to determine the efficacy of nasally inhaled isopropyl alcohol&#xD;
      in alleviating nausea and/or vomiting in patients presenting to the emergency department with&#xD;
      a chief complaint of nausea and/or vomiting. Specifically, this study will determine:&#xD;
&#xD;
        1. Nausea relief: mean reduction in nausea scores using a self-reported nausea scale&#xD;
           comparing the pre-intervention nausea score to the final nausea score at the study&#xD;
           endpoint.&#xD;
&#xD;
        2. Participant satisfaction: self-reported satisfaction scale measured at the study&#xD;
           endpoint.&#xD;
&#xD;
        3. Optimal dosing frequency: compare the reduction in nausea scores among participants&#xD;
           inhaling isopropyl alcohol swabs every 10 minutes, every 20 minutes, and to participants&#xD;
           receiving no intervention.&#xD;
&#xD;
        4. Emergency department management: receipt of rescue anti-emetic medications and other&#xD;
           medications (ie. analgesics, intravenous fluids).&#xD;
&#xD;
        5. Participant disposition: emergency department length of stay and admission to hospital.&#xD;
&#xD;
      OUTCOMES:&#xD;
&#xD;
      The primary outcome reflecting the efficacy of treatment is the mean nausea score reduction,&#xD;
      using a self-reported nausea score comparing the subject's pre-intervention score to the&#xD;
      final nausea score at the study endpoint. Nausea scores will be measured using a&#xD;
      self-reported 10-point verbal numeric scale ranging from 1-10, labeled &quot;no nausea&quot; at the&#xD;
      left end (1) and &quot;worse nausea imaginable&quot; at right end (10). Nausea scores will be measured&#xD;
      at baseline before intervention, 10 minutes post-intervention, 20 minutes post-intervention,&#xD;
      30 minutes post-intervention, and then every 30 minutes for a total of two hours throughout&#xD;
      the subject's emergency department visit.&#xD;
&#xD;
      The secondary outcomes reflecting the efficacy of the study intervention are participant&#xD;
      satisfaction scores, the receipt of any rescue anti-emetic medications, emergency department&#xD;
      length of stay, and participant disposition. Satisfaction scores will be measured using a&#xD;
      self-reported 5-point verbal numeric scale ranging from 1-5, labeled &quot;very unsatisfied&quot; at&#xD;
      the left end (1) and &quot;very satisfied&quot; at the right end (5).&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      This study will be a randomized controlled trial of eligible patients presenting to the&#xD;
      emergency department with a chief complaint of nausea and/or vomiting. Study subjects will be&#xD;
      randomized to one of three subject arms: 1) Nasally inhaled isopropyl alcohol swabs every 10&#xD;
      minutes for a total of one hour; 2) Nasally inhaled isopropyl alcohol swabs every 20 minutes&#xD;
      for a total of one hour; and 3) No intervention arm.&#xD;
&#xD;
      A convenience sample of potential study subjects will be identified by the research team&#xD;
      during periods when available to enroll subjects. Patients will be approached while in the&#xD;
      waiting room or shortly after arrival to their assigned emergency department room, before&#xD;
      arrival of their treating physician and before any treatment is provided.&#xD;
&#xD;
      The allocation sequence will be generated using computer-generated random numbers using&#xD;
      blocks of 6. Concealment will be performed using sealed, opaque envelopes.&#xD;
&#xD;
      STUDY DURATION:&#xD;
&#xD;
      Subject participation will be expected to end at the study endpoint, either after two hours&#xD;
      of collection of nausea scores from the start of treatment or until there is administration&#xD;
      of anti-emetics from the treating physician before the two hours is complete. There will be&#xD;
      no further follow-up. Active study duration will be two hours for each study participant.&#xD;
&#xD;
      SAMPLE SIZE:&#xD;
&#xD;
      The minimally clinically significant difference is assumed to be 3 points on a self-reported&#xD;
      10-point verbal numeric scale ranging from 1-10. For α=0.25 and β=.80 using a t-test, the&#xD;
      sample size required is 45 per participant arm (135 participants total). Imputation will be&#xD;
      used to replace any missing data.&#xD;
&#xD;
      STATISTICAL METHODS:&#xD;
&#xD;
      All analysis will be done by the trial biostatistician. Participant baseline characteristics&#xD;
      will be summarized with descriptive statistics with 95% confidence intervals. The primary&#xD;
      outcome, i.e., mean reduction in nausea scores, will be analyzed using repeated measures&#xD;
      linear regression analysis. Study arm, time and study arm by time will be included as fixed&#xD;
      covariates and the correlation in repeated measures on the same subject over time will be&#xD;
      modeled using a suitable covariance structure. Least square mean differences, together with&#xD;
      95% Confidence Intervals, will be used to express the treatment effect, comparing each of the&#xD;
      intervention arms to the control arm. Statistical significance of each pairwise comparison&#xD;
      will be judged at the 2.5% level to maintain the overall level at 5%. A similar approach will&#xD;
      be used for ED lengths of stay (with transformation to improve normality if necessary).&#xD;
      Number of vomiting episodes and receipt of antiemetic drugs will be analyzed using Poisson or&#xD;
      logistic regression as appropriate. All analyses will be intention to treat. There will be no&#xD;
      interim analysis completed. Imputation will be used to replace any missing data.&#xD;
&#xD;
      QUALITY CONTROL:&#xD;
&#xD;
      The study will have a quality control monitoring process and study monitor plan in place to&#xD;
      verify that all data are accurate and complete. An internal DSMB, free of competing&#xD;
      interests, will monitor the study and will generate a site monitoring report to detail&#xD;
      significant findings, deviations, deficiencies, plausibility, record completeness and any&#xD;
      corrective actions to be taken. The investigator will permit trial-related monitoring,&#xD;
      audits, REB review, and regulatory inspection(s) by providing direct access to source&#xD;
      data/documents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Given the COVID-19 pandemic, there has been a temporary suspension of study activities,&#xD;
    therefore the study has not yet been initiated.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The trial design is open label, given that blinding the scent of alcohol swabs is difficult. As such, no blinding of the study participants nor the research team to interventions will occur, as there will be no placebo intervention given.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nausea scores from pre-intervention to post-intervention</measure>
    <time_frame>From the time of randomization over two hours</time_frame>
    <description>Self-reported 10-point verbal numeric scale ranging from 1-10, labeled &quot;no nausea&quot; at the left end (1) and &quot;worse nausea imaginable&quot; at right end (10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction score</measure>
    <time_frame>From the time of randomization over two hours</time_frame>
    <description>Self-reported 5-point verbal numeric scale ranging from 1-5, labeled &quot;very unsatisfied&quot; at the left end (1) and &quot;very satisfied&quot; at the right end (5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of rescue anti-emetics</measure>
    <time_frame>From the time of randomization until the time of documented emergency department disposition (either admission to hospital or discharge home</time_frame>
    <description>The receipt of any rescue anti-emetics by the treating physician will be recorded, including the medication type(s), and number of doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department length of stay</measure>
    <time_frame>From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home)</time_frame>
    <description>The subject's total emergency department length of stay (in minutes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject disposition</measure>
    <time_frame>From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home</time_frame>
    <description>Subject disposition from the emergency department, either admission to hospital or discharge home.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nausea</condition>
  <condition>Vomiting</condition>
  <arm_group>
    <arm_group_label>Isopropyl alcohol swab every 10 minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes for a total of one hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isopropyl alcohol swab every 20 minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 20 minutes for a total of one hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isopropyl alcohol swab</intervention_name>
    <description>Treatment will be administered by taking one deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes or every 20 minutes for a total of one hour.</description>
    <arm_group_label>Isopropyl alcohol swab every 10 minutes</arm_group_label>
    <arm_group_label>Isopropyl alcohol swab every 20 minutes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age ≥18 years) presenting to the emergency department with a chief&#xD;
             complaint of nausea and/or vomiting with a level of 3 or greater on a verbal numeric&#xD;
             response scale (1-10).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to breathe through nares (ie. rhinitis)&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Have already received an anti-emetic within the past 24 hours (including while in&#xD;
             emergency department triage)&#xD;
&#xD;
          -  Chronic nausea (&gt; 1 month)&#xD;
&#xD;
          -  Known allergy to isopropyl alcohol&#xD;
&#xD;
          -  Nasally sensitive to inhaled chemical products&#xD;
&#xD;
          -  Altered mental status or underlying cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Venkatesh Thiruganasambandomoorthy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Scientist, Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>22513952</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26679977</PMID>
  </reference>
  <reference>
    <citation>April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):184-193. doi: 10.1016/j.annemergmed.2018.01.016. Epub 2018 Feb 17. Erratum In: Ann Emerg Med. 2019 May;73(5):552.</citation>
    <PMID>29463461</PMID>
  </reference>
  <reference>
    <citation>Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31.</citation>
    <PMID>28759346</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26411330</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20022195</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>March 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464915
org study id: 20190789-01H
nct id: NCT04464915
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nausea and vomiting is a common and distressing presenting complaint in Canadian emergency
      departments. Commonly used nausea medications have proven to be effective in certain patient
      populations, for example cancer patients. However, not one has been proven to be more
      effective that the other in the emergency department setting. In addition, many are
      associated with significant side effects and have the potential to interact with a patient's
      home medications. This limits their use in the emergency department until the patient is seen
      and assessed by their treating physician.

      Many studies have shown that nasal inhalation of alcohol swabs is an effective therapy in
      relieving nausea and vomiting in post-operative patients after surgeries. The goal of this
      study will be to determine the effectiveness of alcohol swabs in the emergency department
      setting in relieving nausea and vomiting.
BACKGROUND INFORMATION:

      Emerging evidence exists supporting the use of nasally inhaled isopropyl alcohol swabs as
      anti-emetic therapy. Multiple studies report isopropyl alcohol inhalation as an effective
      treatment for post-operative nausea and vomiting, with no reported adverse events. This
      relatively inexpensive substance is widely available in most health care settings in the form
      of swabs used in the routine course of delivering care as an antiseptic skin cleanser. Two
      previous studies in the United States have evaluated the use of inhaled isopropyl alcohol
      swabs in alleviating nausea and vomiting in the emergency department setting. One study in
      2016 study by Beadle et. al. demonstrated superior nausea relief using inhaled isopropyl
      alcohol swabs compared to an inhaled placebo, while a 2018 study by April et. al.
      demonstrated superior nausea relief with isopropyl alcohol swabs compared with inhaled
      placebo and oral ondansetron.

      The 2016 study by Beadle et. al. has several important limitations. This was a single center
      military hospital study, which only measured nausea scores 10 minutes after isopropyl alcohol
      swab inhalation, and lacked other important outcomes such as the number of vomiting episodes,
      use of rescue anti-emetics, ED length of stay and admission rates. The 2018 study by April
      et. al. also has limitations. Mainly, alcohol swabs were used as often as required by
      participants, and the dosing frequency of inhalations was not measured. They also excluded
      patients who had a peripheral intravenous catheter inserted on arrival, which could suggest
      that patients with more severe symptoms of nausea and vomiting requiring intravenous
      anti-emetics were excluded.

      STUDY RATIONALE:

      The investigator's goal is to add to the current body of evidence on the use of isopropyl
      alcohol in alleviating nausea and vomiting in the emergency department, particularly by
      determining which dosing frequency of isopropyl alcohol inhalation yields the most effective
      nausea relief by randomizing patients to different inhalation frequencies. This may help to
      guide future triage protocols enabling isopropyl alcohol inhalation before provider
      evaluation to improve treatment of nausea and patient satisfaction. In the current state of
      emergency department overcrowding, the ability to adequately control a patient's symptoms at
      triage may help decrease a patient's length of stay, as well as the number of patients
      requiring beds. In addition, from a cost-savings perspective, alcohol swabs are a relatively
      inexpensive therapy as compared to many commonly administered anti-emetics.

      OBJECTIVES:

      The objective of this study is to determine the efficacy of nasally inhaled isopropyl alcohol
      in alleviating nausea and/or vomiting in patients presenting to the emergency department with
      a chief complaint of nausea and/or vomiting. Specifically, this study will determine:

        1. Nausea relief: mean reduction in nausea scores using a self-reported nausea scale
           comparing the pre-intervention nausea score to the final nausea score at the study
           endpoint.

        2. Participant satisfaction: self-reported satisfaction scale measured at the study
           endpoint.

        3. Optimal dosing frequency: compare the reduction in nausea scores among participants
           inhaling isopropyl alcohol swabs every 10 minutes, every 20 minutes, and to participants
           receiving no intervention.

        4. Emergency department management: receipt of rescue anti-emetic medications and other
           medications (ie. analgesics, intravenous fluids).

        5. Participant disposition: emergency department length of stay and admission to hospital.

      OUTCOMES:

      The primary outcome reflecting the efficacy of treatment is the mean nausea score reduction,
      using a self-reported nausea score comparing the subject's pre-intervention score to the
      final nausea score at the study endpoint. Nausea scores will be measured using a
      self-reported 10-point verbal numeric scale ranging from 1-10, labeled "no nausea" at the
      left end (1) and "worse nausea imaginable" at right end (10). Nausea scores will be measured
      at baseline before intervention, 10 minutes post-intervention, 20 minutes post-intervention,
      30 minutes post-intervention, and then every 30 minutes for a total of two hours throughout
      the subject's emergency department visit.

      The secondary outcomes reflecting the efficacy of the study intervention are participant
      satisfaction scores, the receipt of any rescue anti-emetic medications, emergency department
      length of stay, and participant disposition. Satisfaction scores will be measured using a
      self-reported 5-point verbal numeric scale ranging from 1-5, labeled "very unsatisfied" at
      the left end (1) and "very satisfied" at the right end (5).

      STUDY DESIGN:

      This study will be a randomized controlled trial of eligible patients presenting to the
      emergency department with a chief complaint of nausea and/or vomiting. Study subjects will be
      randomized to one of three subject arms: 1) Nasally inhaled isopropyl alcohol swabs every 10
      minutes for a total of one hour; 2) Nasally inhaled isopropyl alcohol swabs every 20 minutes
      for a total of one hour; and 3) No intervention arm.

      A convenience sample of potential study subjects will be identified by the research team
      during periods when available to enroll subjects. Patients will be approached while in the
      waiting room or shortly after arrival to their assigned emergency department room, before
      arrival of their treating physician and before any treatment is provided.

      The allocation sequence will be generated using computer-generated random numbers using
      blocks of 6. Concealment will be performed using sealed, opaque envelopes.

      STUDY DURATION:

      Subject participation will be expected to end at the study endpoint, either after two hours
      of collection of nausea scores from the start of treatment or until there is administration
      of anti-emetics from the treating physician before the two hours is complete. There will be
      no further follow-up. Active study duration will be two hours for each study participant.

      SAMPLE SIZE:

      The minimally clinically significant difference is assumed to be 3 points on a self-reported
      10-point verbal numeric scale ranging from 1-10. For α=0.25 and β=.80 using a t-test, the
      sample size required is 45 per participant arm (135 participants total). Imputation will be
      used to replace any missing data.

      STATISTICAL METHODS:

      All analysis will be done by the trial biostatistician. Participant baseline characteristics
      will be summarized with descriptive statistics with 95% confidence intervals. The primary
      outcome, i.e., mean reduction in nausea scores, will be analyzed using repeated measures
      linear regression analysis. Study arm, time and study arm by time will be included as fixed
      covariates and the correlation in repeated measures on the same subject over time will be
      modeled using a suitable covariance structure. Least square mean differences, together with
      95% Confidence Intervals, will be used to express the treatment effect, comparing each of the
      intervention arms to the control arm. Statistical significance of each pairwise comparison
      will be judged at the 2.5% level to maintain the overall level at 5%. A similar approach will
      be used for ED lengths of stay (with transformation to improve normality if necessary).
      Number of vomiting episodes and receipt of antiemetic drugs will be analyzed using Poisson or
      logistic regression as appropriate. All analyses will be intention to treat. There will be no
      interim analysis completed. Imputation will be used to replace any missing data.

      QUALITY CONTROL:

      The study will have a quality control monitoring process and study monitor plan in place to
      verify that all data are accurate and complete. An internal DSMB, free of competing
      interests, will monitor the study and will generate a site monitoring report to detail
      significant findings, deviations, deficiencies, plausibility, record completeness and any
      corrective actions to be taken. The investigator will permit trial-related monitoring,
      audits, REB review, and regulatory inspection(s) by providing direct access to source
      data/documents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: The trial design is open label, given that blinding the scent of alcohol swabs is difficult. As such, no blinding of the study participants nor the research team to interventions will occur, as there will be no placebo intervention given.
measure: Change in nausea scores from pre-intervention to post-intervention
time frame: From the time of randomization over two hours
description: Self-reported 10-point verbal numeric scale ranging from 1-10, labeled "no nausea" at the left end (1) and "worse nausea imaginable" at right end (10).
measure: Subject satisfaction score
time frame: From the time of randomization over two hours
description: Self-reported 5-point verbal numeric scale ranging from 1-5, labeled "very unsatisfied" at the left end (1) and "very satisfied" at the right end (5).
measure: Receipt of rescue anti-emetics
time frame: From the time of randomization until the time of documented emergency department disposition (either admission to hospital or discharge home
description: The receipt of any rescue anti-emetics by the treating physician will be recorded, including the medication type(s), and number of doses.
measure: Emergency department length of stay
time frame: From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home)
description: The subject's total emergency department length of stay (in minutes).
measure: Subject disposition
time frame: From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home
description: Subject disposition from the emergency department, either admission to hospital or discharge home.
arm group label: Isopropyl alcohol swab every 10 minutes
arm group type: Experimental
description: One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes for a total of one hour.
arm group label: Isopropyl alcohol swab every 20 minutes
arm group type: Experimental
description: One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 20 minutes for a total of one hour.
arm group label: No treatment arm
arm group type: No Intervention
description: No intervention administered.
intervention type: Other
intervention name: Isopropyl alcohol swab
description: Treatment will be administered by taking one deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes or every 20 minutes for a total of one hour.
arm group label: Isopropyl alcohol swab every 10 minutes
arm group label: Isopropyl alcohol swab every 20 minutes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Venkatesh Thiruganasambandomoorthy, MD
role: Principal Investigator
affiliation: Senior Scientist, Ottawa Hospital Research Institute
facility: 
country: Canada
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.
PMID: 22513952
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.
PMID: 26679977
citation: April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):184-193. doi: 10.1016/j.annemergmed.2018.01.016. Epub 2018 Feb 17. Erratum In: Ann Emerg Med. 2019 May;73(5):552.
PMID: 29463461
citation: Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31.
PMID: 28759346
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.
PMID: 26411330
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.
PMID: 20022195
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Vomiting
sharing ipd: No