<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/NCT02980172</url>
  </required_header>
  <id_info>
    <org_study_id>CCER 2016-00205</org_study_id>
    <nct_id>NCT02980172</nct_id>
  </id_info>
  <brief_title>Pain Evaluation and Treatment in the Emergency Department</brief_title>
  <official_title>Pain Evaluation and Treatment in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are&#xD;
      triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.&#xD;
      At the end of the triage process the triage nurse has to choose an emergency level and a main&#xD;
      presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain&#xD;
      evaluation for 44 out of the SETS 98 presenting complaint.&#xD;
&#xD;
      The primary objective of the study is to determine whether pain is correctly evaluated when&#xD;
      required by the SETS criteria. The secondary objectives are (1) to evaluate whether an&#xD;
      appropriate treatment is delivered when pain is present, and (2) to identify predictors of&#xD;
      pain evaluation and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are&#xD;
      triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.&#xD;
      At the end of the triage process the triage nurse has to choose an emergency level and a main&#xD;
      presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain&#xD;
      evaluation for 44 out of the SETS 98 presenting complaint.&#xD;
&#xD;
      After this evaluation, a protocol standardize administration of analgesia for patients&#xD;
      presenting pain.&#xD;
&#xD;
      The primary objective of the study is to determine whether pain is correctly evaluated when&#xD;
      required by the SETS criteria for the 44 presenting complaints.&#xD;
&#xD;
      The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered&#xD;
      when pain is present, and (2) to identify predictors of pain evaluation and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with appropriate pain evaluation</measure>
    <time_frame>Within 24 hours after ED admission</time_frame>
    <description>Percentage of patients with a documented assessement of pain using a numerical scale (0 to 10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with appropriate pain treatment</measure>
    <time_frame>Within 24 hours after ED admission</time_frame>
    <description>Percentage of patients who received an appropriate treatment accordingly to the ED recommendations.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">31942</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>Pain triage complaint</arm_group_label>
    <description>Patients admitted at GUH ED triaged with a main complaint requiring a pain evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain evaluation</intervention_name>
    <description>Evaluation of pain using a numerical scale (1 to 10)</description>
    <arm_group_label>Pain triage complaint</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted during one year at GUH ED.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (&gt;= 16y) patients admitted at GUH ED during one year&#xD;
&#xD;
          -  presenting complaint requiring pain evaluation accordingly to the SETS criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 16 y&#xD;
&#xD;
          -  presenting complaint that does not require a pain evaluation accordingly to the SETS&#xD;
             criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier T Rutschmann, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geneva University Hospitals, ED</name>
      <address>
        <city>Geneva</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Olivier T. Rutschmann</investigator_full_name>
    <investigator_title>Professor, Deputy Chief</investigator_title>
  </responsible_party>
  <keyword>triage</keyword>
  <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>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/NCT02980172
org study id: CCER 2016-00205
nct id: NCT02980172
lead sponsor: 
has dmc: No
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are
      triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.
      At the end of the triage process the triage nurse has to choose an emergency level and a main
      presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain
      evaluation for 44 out of the SETS 98 presenting complaint.

      The primary objective of the study is to determine whether pain is correctly evaluated when
      required by the SETS criteria. The secondary objectives are (1) to evaluate whether an
      appropriate treatment is delivered when pain is present, and (2) to identify predictors of
      pain evaluation and treatment.
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are
      triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.
      At the end of the triage process the triage nurse has to choose an emergency level and a main
      presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain
      evaluation for 44 out of the SETS 98 presenting complaint.

      After this evaluation, a protocol standardize administration of analgesia for patients
      presenting pain.

      The primary objective of the study is to determine whether pain is correctly evaluated when
      required by the SETS criteria for the 44 presenting complaints.

      The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered
      when pain is present, and (2) to identify predictors of pain evaluation and treatment.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of patients with appropriate pain evaluation
time frame: Within 24 hours after ED admission
description: Percentage of patients with a documented assessement of pain using a numerical scale (0 to 10)
measure: Proportion of patients with appropriate pain treatment
time frame: Within 24 hours after ED admission
description: Percentage of patients who received an appropriate treatment accordingly to the ED recommendations.
arm group label: Pain triage complaint
description: Patients admitted at GUH ED triaged with a main complaint requiring a pain evaluation.
intervention type: Other
intervention name: Pain evaluation
description: Evaluation of pain using a numerical scale (1 to 10)
arm group label: Pain triage complaint
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier T Rutschmann, MD, MPH
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Olivier T. Rutschmann
investigator title: Professor, Deputy Chief
mesh term: Emergencies
mesh term: Acute Pain
sharing ipd: No