<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/NCT03278652</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3033_NEPHROPAIN</org_study_id>
    <nct_id>NCT03278652</nct_id>
  </id_info>
  <brief_title>Use of Analgesic Drugs in Renal Colic in Emergency Room</brief_title>
  <acronym>NEPHROPAIN</acronym>
  <official_title>Use of Analgesic Drugs in Renal Colic in Emergency Room</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes 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>
      A prospective non-interventional study on the use of analgesic drugs in renal colic in&#xD;
      emergency rooms&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 19, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol</measure>
    <time_frame>During hospitalisation in emergency rooms</time_frame>
    <description>Collection of name, dosage, route of administration, time of issue of the drug</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Renal Colic</condition>
  <arm_group>
    <arm_group_label>Patient with renal colic</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Consumption of drugs for analgesic use</intervention_name>
    <description>Regular assessment of pain&#xD;
Drug data will be collected (name, dosage, route of administration, time of delivery)</description>
    <arm_group_label>Patient with renal colic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with renal colic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  Suspicion of renal colic (pain in a lumbar pit radiating to the external genital&#xD;
             organs, rapidly progressive onset, non-febrile)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shock&#xD;
&#xD;
          -  Glasgow score less than 15&#xD;
&#xD;
          -  Oxygen saturation less than 93% in ambient air&#xD;
&#xD;
          -  Signs of intracranial hypertension (headache associated with vomiting)&#xD;
&#xD;
          -  Suspicion of pneumothorax&#xD;
&#xD;
          -  History of emphysema or chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Diving accident or suspicion of gas embolism&#xD;
&#xD;
          -  Trauma of the face of interest in the area of application of the mask&#xD;
&#xD;
          -  Abdominal gas distension&#xD;
&#xD;
          -  Contraindication in Nonsteroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Pregnancy&#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_contact>
    <last_name>Alexandre Tanneau, MD</last_name>
    <phone>02.99.28.60.48</phone>
    <email>alexandre.tanneau@chu-rennes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre Tanneau, MD</last_name>
      <phone>02.99.28.60.48</phone>
      <email>alexandre.tanneau@chu-rennes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</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 11, 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>Colic</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Renal Colic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</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/NCT03278652
org study id: 35RC16_3033_NEPHROPAIN
nct id: NCT03278652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective non-interventional study on the use of analgesic drugs in renal colic in
      emergency rooms
observational model: Case-Only
time perspective: Prospective
measure: Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol
time frame: During hospitalisation in emergency rooms
description: Collection of name, dosage, route of administration, time of issue of the drug
arm group label: Patient with renal colic
intervention type: Other
intervention name: Consumption of drugs for analgesic use
description: Regular assessment of pain
Drug data will be collected (name, dosage, route of administration, time of delivery)
arm group label: Patient with renal colic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre Tanneau, MD
phone: 02.99.28.60.48
email: alexandre.tanneau@chu-rennes.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Colic
mesh term: Emergencies
mesh term: Renal Colic
mesh term: Analgesics
sharing ipd: No