<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/NCT01686009</url>
  </required_header>
  <id_info>
    <org_study_id>UBC Dept of EM</org_study_id>
    <nct_id>NCT01686009</nct_id>
  </id_info>
  <brief_title>Intra-nasal Ketamine for Analgesia in the Emergency Department</brief_title>
  <acronym>INKA</acronym>
  <official_title>Intra-nasal Ketamine for Analgesia in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lions Gate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Shore Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lions Gate Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The provision of analgesia to patients in pain is a fundamental necessity of emergency&#xD;
      department practice and is usually accomplished using IV opioids. However, significant&#xD;
      barriers exist to the provision of timely analgesia by the IV route.&#xD;
&#xD;
      The use of the IN route for medication delivery provides an efficient and relatively painless&#xD;
      mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and&#xD;
      to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring&#xD;
      that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid,&#xD;
      easy-administered and well-tolerated method for providing analgesia in the ED setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median maximum reduction in VAS pain score achieved within 30 minutes</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median time required to achieve a 13-mm reduction in VAS pain score</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs changes (ETCO2, O2sat, HR, RR, BP)</measure>
    <time_frame>1 hour</time_frame>
    <description>Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects as defined by SERSDA</measure>
    <time_frame>1 hour</time_frame>
    <description>SERSDA (Side Effect Rating Scale for Dissociative Anaesthesia) includes: fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, changes in vision, mood change, generalized discomfort, and hallucination.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Intra-nasal ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intra-nasal ketamine</intervention_name>
    <arm_group_label>Intra-nasal ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 6 years or greater&#xD;
&#xD;
          -  moderate or severe pain (VAS &gt;=50mm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of allergy or intolerance to ketamine&#xD;
&#xD;
          -  structural or functional nasal occlusion&#xD;
&#xD;
          -  inability to understand the VAS&#xD;
&#xD;
          -  Glasgow Coma Scale &lt; 15&#xD;
&#xD;
          -  Systolic BP &gt; 180&#xD;
&#xD;
          -  History of schizophrenia&#xD;
&#xD;
          -  Clinical necessity for immediate IV access as judged by the treating physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary Andolfatto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UBC Dept of EM; Lions Gate Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lions Gate Hospital</name>
      <address>
        <city>North Vancouver</city>
        <state>British Columbia</state>
        <zip>V7L 2L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>February 3, 2013</last_update_submitted>
  <last_update_submitted_qc>February 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lions Gate Hospital</investigator_affiliation>
    <investigator_full_name>Gary Andolfatto</investigator_full_name>
    <investigator_title>Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>analgesia</keyword>
  <keyword>ketamine</keyword>
  <keyword>intranasal</keyword>
  <keyword>emergency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01686009
org study id: UBC Dept of EM
nct id: NCT01686009
lead sponsor: 
collaborator: 
has dmc: No
The provision of analgesia to patients in pain is a fundamental necessity of emergency
      department practice and is usually accomplished using IV opioids. However, significant
      barriers exist to the provision of timely analgesia by the IV route.

      The use of the IN route for medication delivery provides an efficient and relatively painless
      mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and
      to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring
      that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid,
      easy-administered and well-tolerated method for providing analgesia in the ED setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.
time frame: 30 minutes
measure: Median maximum reduction in VAS pain score achieved within 30 minutes
time frame: 30 minutes
measure: Median time required to achieve a 13-mm reduction in VAS pain score
time frame: 1 hour
measure: Vital signs changes (ETCO2, O2sat, HR, RR, BP)
time frame: 1 hour
description: Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes
measure: Adverse effects as defined by SERSDA
time frame: 1 hour
description: SERSDA (Side Effect Rating Scale for Dissociative Anaesthesia) includes: fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, changes in vision, mood change, generalized discomfort, and hallucination.
arm group label: Intra-nasal ketamine
arm group type: Experimental
description: 0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
intervention type: Drug
intervention name: Intra-nasal ketamine
arm group label: Intra-nasal ketamine
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Gary Andolfatto, MD
role: Principal Investigator
affiliation: UBC Dept of EM; Lions Gate Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lions Gate Hospital
investigator full name: Gary Andolfatto
investigator title: Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital
mesh term: Emergencies
mesh term: Ketamine