<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/NCT03760302</url>
  </required_header>
  <id_info>
    <org_study_id>AN2015-0068 347/4.13 381/5.19</org_study_id>
    <nct_id>NCT03760302</nct_id>
  </id_info>
  <brief_title>Analgesia in ÖAMTC Helicopter Emergency Service in Austria</brief_title>
  <official_title>Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</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>
      A sufficient analgesia in injured or sick people is the main goal of physicians treating a&#xD;
      patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used.&#xD;
      It is unknown if there are any severe side effects or if the use is safe while in use in a&#xD;
      Helicopter Emergency Service equipped with emergency physicians.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">October 26, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful analgesia</measure>
    <time_frame>2000-2016</time_frame>
    <description>Change in reported pain severity before and after treatment with analgesic. (Numeric Rating Scale, NRS, eleven-point scale reporting no pain=0, to maximum pain=10; 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgesic, drug type</measure>
    <time_frame>2000-2016</time_frame>
    <description>Use of analgesic (n= type of analgesic)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgesic, frequency</measure>
    <time_frame>2000-2016</time_frame>
    <description>Use of analgesic (n= frequency how often analgesic is used)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgesic, amount of analgesics</measure>
    <time_frame>2000-2016</time_frame>
    <description>Use of analgesic (n= amount of analgesic used in mg or µg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>2000-2016</time_frame>
    <description>Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2&lt;90%), dead)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of side effects</measure>
    <time_frame>2000-2016</time_frame>
    <description>Frequency of side effects (frequency of side effect/n=total number of analgesic use; very common&gt;=1/10, common&gt;=1/100 and&lt;1/10, uncommon &gt;=1/1000 and &lt;1/100, rare &gt;=1/10000 and &lt;1/1000, very rare &lt;1/10000)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of side effect</measure>
    <time_frame>2000-2016</time_frame>
    <description>severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35000</enrollment>
  <condition>Field Physician Care</condition>
  <condition>Analgesics</condition>
  <condition>Hypnotics</condition>
  <condition>Emergencies</condition>
  <condition>Safety</condition>
  <condition>Accident</condition>
  <condition>Trauma, Multiple</condition>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Patient given analgesics or hypnotics</arm_group_label>
    <description>All patients treated with any kind of analgesics or hypnotics are analyzed and compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>analgesics</intervention_name>
    <description>analgesics given to a patient treated from HEMS</description>
    <arm_group_label>Patient given analgesics or hypnotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hypnotics</intervention_name>
    <description>hypnotics given to a patient treated from HEMS</description>
    <arm_group_label>Patient given analgesics or hypnotics</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients screened with the described inclusion criteria - eligible to be included in&#xD;
        analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service.&#xD;
             Analgesia given not in the period of examination (2000-2016)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathias Ströhle, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>General and Surgical Critical Care Medicine, Medical University of Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General and Surgical Critical Care Medicine, Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</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>Acute Pain</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Hypnotics and Sedatives</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/NCT03760302
org study id: AN2015-0068 347/4.13 381/5.19
nct id: NCT03760302
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A sufficient analgesia in injured or sick people is the main goal of physicians treating a
      patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used.
      It is unknown if there are any severe side effects or if the use is safe while in use in a
      Helicopter Emergency Service equipped with emergency physicians.
observational model: Case-Only
time perspective: Retrospective
measure: Successful analgesia
time frame: 2000-2016
description: Change in reported pain severity before and after treatment with analgesic. (Numeric Rating Scale, NRS, eleven-point scale reporting no pain=0, to maximum pain=10; 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain)
measure: Analgesic, drug type
time frame: 2000-2016
description: Use of analgesic (n= type of analgesic)
measure: Analgesic, frequency
time frame: 2000-2016
description: Use of analgesic (n= frequency how often analgesic is used)
measure: Analgesic, amount of analgesics
time frame: 2000-2016
description: Use of analgesic (n= amount of analgesic used in mg or µg)
measure: Side effects
time frame: 2000-2016
description: Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead)
measure: Frequency of side effects
time frame: 2000-2016
description: Frequency of side effects (frequency of side effect/n=total number of analgesic use; very common>=1/10, common>=1/100 and<1/10, uncommon >=1/1000 and <1/100, rare >=1/10000 and <1/1000, very rare <1/10000)
measure: Severity of side effect
time frame: 2000-2016
description: severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening)
arm group label: Patient given analgesics or hypnotics
description: All patients treated with any kind of analgesics or hypnotics are analyzed and compared.
intervention type: Other
intervention name: analgesics
description: analgesics given to a patient treated from HEMS
arm group label: Patient given analgesics or hypnotics
intervention type: Other
intervention name: hypnotics
description: hypnotics given to a patient treated from HEMS
arm group label: Patient given analgesics or hypnotics
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mathias Ströhle, Dr
role: Principal Investigator
affiliation: General and Surgical Critical Care Medicine, Medical University of Innsbruck
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Acute Pain
mesh term: Multiple Trauma
mesh term: Analgesics
mesh term: Hypnotics and Sedatives
sharing ipd: No