<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/NCT02973568</url>
  </required_header>
  <id_info>
    <org_study_id>DASAU</org_study_id>
    <nct_id>NCT02973568</nct_id>
  </id_info>
  <brief_title>Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit</brief_title>
  <acronym>DASAU</acronym>
  <official_title>Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario de Canarias</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain&#xD;
      care with a consultations rate in emergency center of more than 60%.For example&#xD;
      OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.&#xD;
&#xD;
      In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France&#xD;
      (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies&#xD;
      relative to chronic pain but not too much about acute pain in Spain.That's why we want to&#xD;
      focus our study on evaluation of acute pain treatment and efficacy in french and spanish&#xD;
      hospital&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1, 2016</start_date>
  <completion_date type="Actual">July 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain VAS (visual analogic scale)</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <enrollment type="Actual">641</enrollment>
  <condition>Pain</condition>
  <condition>EMERGENCY MEDICINE</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational Study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Evety patient admitted in emergency center during 1 month for acute pain and who need&#xD;
        treatment for pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted in emergency center for acute pain.&#xD;
&#xD;
          -  Patient who accept to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of patient to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonay PERERA GIL, PhD student</last_name>
    <role>Study Director</role>
    <affiliation>Groupe Hospitalier Paris Saint-Joseph (FRANCE)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olivier GANANSIA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02973568
org study id: DASAU
nct id: NCT02973568
lead sponsor: 
collaborator: 
has dmc: Yes
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain
      care with a consultations rate in emergency center of more than 60%.For example
      OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.

      In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France
      (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies
      relative to chronic pain but not too much about acute pain in Spain.That's why we want to
      focus our study on evaluation of acute pain treatment and efficacy in french and spanish
      hospital
observational model: Cohort
time perspective: Prospective
measure: pain VAS (visual analogic scale)
time frame: 1 hour
intervention type: Other
intervention name: Observational Study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jonay PERERA GIL, PhD student
role: Study Director
affiliation: Groupe Hospitalier Paris Saint-Joseph (FRANCE)
last name: Olivier GANANSIA, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Acute Pain
sharing ipd: Undecided