<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/NCT03236805</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0082</org_study_id>
    <nct_id>NCT03236805</nct_id>
  </id_info>
  <brief_title>Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia</brief_title>
  <acronym>KETAMORPH</acronym>
  <official_title>Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, randomized, single-blind trial evaluating prehospital patients&#xD;
      experiencing moderate to severe acute pain, defined as a numeric rating scale score greater&#xD;
      than or equal to 5. Patients will be randomized to receive ketamine at or morphine by&#xD;
      intravenous push.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate if ketamine alone is non inferior to morphine alone for&#xD;
      prehospital analgesia. Numeric rating scale pain scores will be compared between recipients&#xD;
      of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at&#xD;
      hospital admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    285 patients have recruited instead on 496 but we don't want to continue to prolonge the study.&#xD;
    Analysis will be performed on the data we have.&#xD;
  </why_stopped>
  <start_date type="Actual">November 23, 2017</start_date>
  <completion_date type="Actual">November 26, 2022</completion_date>
  <primary_completion_date type="Actual">November 26, 2022</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.</measure>
    <time_frame>45 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">285</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Ketamine IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine IV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Initial bolus of 20 mg (around 0.3 mg per kg) followed by bolus of 10 mg every 5 minutes as reported by the recommandations of experts of the french society of urgency care</description>
    <arm_group_label>Ketamine IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Bolus of 2 mg (patient with weight under 60 kgs) or bolus of 3 mg (patient with weight above 60 kgs) every 5 minutes as reported by the recommandations of experts of the french society of urgency care</description>
    <arm_group_label>Morphine IV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years old&#xD;
&#xD;
          -  prehospital moderate to severe acute pain, defined as a numeric rating scale score&#xD;
             greater than or equal to 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable vital signs (systolic blood pressure &lt;90 or &gt;200 mm Hg, pulse rate &lt;50 or&#xD;
             &gt;150 beats/min, and respiration rate &lt;10 or &gt;30 breaths/min)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breast-feeding&#xD;
&#xD;
          -  altered mental status&#xD;
&#xD;
          -  unable to give numeric rating scale scores&#xD;
&#xD;
          -  allergy to morphine or ketamine&#xD;
&#xD;
          -  acute pulmonary edema&#xD;
&#xD;
          -  acute coronary syndrome&#xD;
&#xD;
          -  renal or hepatic insufficiency&#xD;
&#xD;
          -  patient who received morphine for the same acute pain&#xD;
&#xD;
          -  acute psychiatric illness&#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>Joel JENVRIN, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Chateaubriant</name>
      <address>
        <city>Chateaubriant</city>
        <zip>44146</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Gonesse</name>
      <address>
        <city>Gonesse</city>
        <zip>95500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Roche sur Yon Hospital</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Mans University Hospital</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quimper Hospital</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Saint Nazaire</name>
      <address>
        <city>Saint-Nazaire</city>
        <zip>44600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tours University Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Morphine</keyword>
  <keyword>Ketamine</keyword>
  <keyword>Acute pain</keyword>
  <keyword>prehospital</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_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/NCT03236805
org study id: RC17_0082
nct id: NCT03236805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized, single-blind trial evaluating prehospital patients
      experiencing moderate to severe acute pain, defined as a numeric rating scale score greater
      than or equal to 5. Patients will be randomized to receive ketamine at or morphine by
      intravenous push.
This study is designed to evaluate if ketamine alone is non inferior to morphine alone for
      prehospital analgesia. Numeric rating scale pain scores will be compared between recipients
      of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at
      hospital admission.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.
time frame: 30 minutes
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.
time frame: 15 minutes
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.
time frame: 45 minutes
measure: Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.
time frame: 60 minutes
arm group label: Ketamine IV
arm group type: Experimental
arm group label: Morphine IV
arm group type: Active Comparator
intervention type: Drug
intervention name: Ketamine
description: Initial bolus of 20 mg (around 0.3 mg per kg) followed by bolus of 10 mg every 5 minutes as reported by the recommandations of experts of the french society of urgency care
arm group label: Ketamine IV
intervention type: Drug
intervention name: Morphine
description: Bolus of 2 mg (patient with weight under 60 kgs) or bolus of 3 mg (patient with weight above 60 kgs) every 5 minutes as reported by the recommandations of experts of the french society of urgency care
arm group label: Morphine IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel JENVRIN, Doctor
role: Principal Investigator
affiliation: Nantes University Hospital
facility: 
facility: 
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country: France
responsible party type: Sponsor
mesh term: Ketamine
mesh term: Morphine
sharing ipd: No