<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/NCT03243006</url>
  </required_header>
  <id_info>
    <org_study_id>Triage treatment</org_study_id>
    <nct_id>NCT03243006</nct_id>
  </id_info>
  <brief_title>Effect of Early Pain Management at Triage on Opioid Consumption</brief_title>
  <official_title>Effect of Early Analgesic Treatment on Opioid Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</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>
      introduction: Pain remains one of the most common reasons of emergency department admission.&#xD;
      Opioids are overprescribed in emergency departments to treat severe pain.&#xD;
&#xD;
      objective: assessing the impact of ealy pain pain management on the use of intravenous&#xD;
      morphine and on patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">September 30, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>use of rescue opioids</measure>
    <time_frame>DURING emergency department stay</time_frame>
    <description>decreased consumption of intravenous morphine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>When quitting emergency department</time_frame>
    <description>patient satisfaction regarding the overall management in the emergency department measured by likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of emergency department stay</measure>
    <time_frame>Until emergency department discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity at emergency department discharge</measure>
    <time_frame>At emergency department discharge</time_frame>
    <description>Percentage of patients with visual analog scale &lt;30</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1500</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>group Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this group (Placebo Oral Tablet) received two placebo tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group Paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group received two 500 mg paracetamol tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group Tramadol/Paracetamol combination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>2 tablets of 500mg of paracetamol</description>
    <arm_group_label>group Paracetamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol/Paracetamol combination</intervention_name>
    <description>2 tablets of tramadol/paracetamol combination (32.5mg/325mg)</description>
    <arm_group_label>group Tramadol/Paracetamol combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>2 tablets of placebo</description>
    <arm_group_label>group Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
          -  a visual analog scale (VAS) equal to or higher than 30/100 ,&#xD;
&#xD;
          -  having given consent to participation&#xD;
&#xD;
          -  No contraindications to products used in the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having a vital distress that does not allow an adequate assessment of the intensity of&#xD;
             the pain&#xD;
&#xD;
          -  an inability to assess pain intensity according to the VAS,&#xD;
&#xD;
          -  swallowing disorders or inability , or a contraindication or an allergy to the&#xD;
             treatments used.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>November 28, 2017</last_update_submitted>
  <last_update_submitted_qc>November 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>acute pain</keyword>
  <keyword>emergency department</keyword>
  <keyword>opioid consumption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Tramadol</mesh_term>
  </intervention_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/NCT03243006
org study id: Triage treatment
nct id: NCT03243006
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
introduction: Pain remains one of the most common reasons of emergency department admission.
      Opioids are overprescribed in emergency departments to treat severe pain.

      objective: assessing the impact of ealy pain pain management on the use of intravenous
      morphine and on patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: use of rescue opioids
time frame: DURING emergency department stay
description: decreased consumption of intravenous morphine
measure: patient satisfaction
time frame: When quitting emergency department
description: patient satisfaction regarding the overall management in the emergency department measured by likert scale
measure: Length of emergency department stay
time frame: Until emergency department discharge
measure: Pain intensity at emergency department discharge
time frame: At emergency department discharge
description: Percentage of patients with visual analog scale <30
arm group label: group Placebo
arm group type: Placebo Comparator
description: Patients in this group (Placebo Oral Tablet) received two placebo tablets
arm group label: group Paracetamol
arm group type: Active Comparator
description: Patients in this group received two 500 mg paracetamol tablets
arm group label: group Tramadol/Paracetamol combination
arm group type: Active Comparator
description: Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)
intervention type: Drug
intervention name: Paracetamol
description: 2 tablets of 500mg of paracetamol
arm group label: group Paracetamol
intervention type: Drug
intervention name: Tramadol/Paracetamol combination
description: 2 tablets of tramadol/paracetamol combination (32.5mg/325mg)
arm group label: group Tramadol/Paracetamol combination
intervention type: Drug
intervention name: Placebo Oral Tablet
description: 2 tablets of placebo
arm group label: group Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: professor
mesh term: Acute Pain
mesh term: Acetaminophen
mesh term: Tramadol
sharing ipd: Undecided