<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/NCT01685658</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2012/PGC-01</org_study_id>
    <secondary_id>2015-002381-23</secondary_id>
    <nct_id>NCT01685658</nct_id>
  </id_info>
  <brief_title>Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations</brief_title>
  <acronym>PIVKIV</acronym>
  <official_title>Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study was to demonstrate the non-inferiority of intravenous&#xD;
      paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency&#xD;
      ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30&#xD;
      minutes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary objectives of this study are:&#xD;
&#xD;
        -  To compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at&#xD;
           90 minutes (vns for pain).&#xD;
&#xD;
        -  To compare both arms in terms of other administered drugs (for pain).&#xD;
&#xD;
        -  To observe and compare side effects between the two arms: cutaneous manifestation,&#xD;
           edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness,&#xD;
           disturbance of consciousness, dyspnea, acute retention of urine.&#xD;
&#xD;
        -  To determine predictors for the use of intravenous morphine when treating renal colic.&#xD;
&#xD;
        -  To compare hospitalization rates between the two groups.&#xD;
&#xD;
        -  To compare patient satisfaction concerning care between the two groups (vns for&#xD;
           satisfaction)&#xD;
&#xD;
        -  To observe and compare changes towards complicated renal colic (obstructive&#xD;
           pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis,&#xD;
           death)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    same study already published&#xD;
  </why_stopped>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in vns for pain</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>Verbal numeric scale ranging from 0 to 10.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in vns for pain</measure>
    <time_frame>baseline to 90 minutes</time_frame>
    <description>Verbal numeric scale ranging from 0 to 10.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) tramadol administered</measure>
    <time_frame>baseline (minute 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) tramadol administered</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) tramadol administered</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) tramadol administered</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) phloroglucinol administered</measure>
    <time_frame>baseline (minute 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) phloroglucinol administered</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) phloroglucinol administered</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) phloroglucinol administered</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Was morphine administered? yes/no</measure>
    <time_frame>baseline (minute 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) morphine administered</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) morphine administered</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) morphine administered</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Nefopam administered</measure>
    <time_frame>baseline (minute 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Nefopam administered</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Nefopam administered</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Nefopam administered</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Alfuzosine administered</measure>
    <time_frame>baseline (minute 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Alfuzosine administered</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Alfuzosine administered</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of (posology) Alfuzosine administered</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/absence of complications</measure>
    <time_frame>baseline (minute 0)</time_frame>
    <description>cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/absence of complications</measure>
    <time_frame>30 minutes</time_frame>
    <description>cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/absence of complications</measure>
    <time_frame>90 minutes</time_frame>
    <description>cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/absence of complications</measure>
    <time_frame>week 1</time_frame>
    <description>cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Was the patient hospitalized? yes/no</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Was the patient hospitalized? yes/no</measure>
    <time_frame>week 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VNS for patient satisfaction concerning care</measure>
    <time_frame>week 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution towards a complicated renal colic</measure>
    <time_frame>discharge from emergency ward (estimated max of 24 hours)</time_frame>
    <description>Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution towards a complicated renal colic</measure>
    <time_frame>week 1</time_frame>
    <description>Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Renal Colic</condition>
  <condition>Acute Renal Colic</condition>
  <arm_group>
    <arm_group_label>Ketaprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.&#xD;
Intervention: intravenous ketaprofen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.&#xD;
Intervention: intravenous paracetamol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous ketoprofen</intervention_name>
    <description>Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)</description>
    <arm_group_label>Ketaprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous paracetamol</intervention_name>
    <description>Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)</description>
    <arm_group_label>Paracetamol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given his/her informed and signed consent&#xD;
&#xD;
          -  The patient must be insured or beneficiary of a health insurance plan&#xD;
&#xD;
          -  The patient is available for a telephone interview at week 1&#xD;
&#xD;
          -  Patient consulting at the Nîmes University Hospital emergency ward with suspicion of&#xD;
             renal colic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is participating in another study&#xD;
&#xD;
          -  The patient is in an exclusion period determined by a previous study&#xD;
&#xD;
          -  The patient is under judicial protection, under tutorship or curatorship&#xD;
&#xD;
          -  The patient refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to correctly inform the patient&#xD;
&#xD;
          -  The patient is pregnant, parturient, or breastfeeding&#xD;
&#xD;
          -  The patient has a contraindication for a treatment used in this study&#xD;
&#xD;
          -  The patient has an allergy to ketoprofen or paracetamol, a history of gastric or&#xD;
             intestinal ulcers, bleeding disorders, history of asthma triggered by taking&#xD;
             ketoprofen or substances with similar activity such as other NSAIDs or aspirin&#xD;
&#xD;
          -  The patient has a fever or is hemodynamically unstable, oligoanuria&#xD;
&#xD;
          -  The patient presents with an initial verbal numeric pain score of 10/10.&#xD;
&#xD;
          -  The patient has a history of aneurysm or aortic dissection, history of renal&#xD;
             transplantation, history of renal or hepatic insufficiency&#xD;
&#xD;
          -  The patient took paracetamol or ketoprofen 4 hours before emergency treatment.&#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_official>
    <last_name>Pierre-Géraud Claret, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nîmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH d'Alès</name>
      <address>
        <city>Alès</city>
        <zip>30103</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nîmes - Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes Cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</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>Acetaminophen</mesh_term>
    <mesh_term>Ketoprofen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01685658
org study id: LOCAL/2012/PGC-01
secondary id: 2015-002381-23
nct id: NCT01685658
lead sponsor: 
has dmc: No
The main objective of this study was to demonstrate the non-inferiority of intravenous
      paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency
      ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30
      minutes.
The secondary objectives of this study are:

        -  To compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at
           90 minutes (vns for pain).

        -  To compare both arms in terms of other administered drugs (for pain).

        -  To observe and compare side effects between the two arms: cutaneous manifestation,
           edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness,
           disturbance of consciousness, dyspnea, acute retention of urine.

        -  To determine predictors for the use of intravenous morphine when treating renal colic.

        -  To compare hospitalization rates between the two groups.

        -  To compare patient satisfaction concerning care between the two groups (vns for
           satisfaction)

        -  To observe and compare changes towards complicated renal colic (obstructive
           pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis,
           death)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in vns for pain
time frame: baseline to 30 minutes
description: Verbal numeric scale ranging from 0 to 10.0.
measure: Change in vns for pain
time frame: baseline to 90 minutes
description: Verbal numeric scale ranging from 0 to 10.0.
measure: Quantity of (posology) tramadol administered
time frame: baseline (minute 0)
measure: Quantity of (posology) tramadol administered
time frame: 30 minutes
measure: Quantity of (posology) tramadol administered
time frame: 90 minutes
measure: Quantity of (posology) tramadol administered
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) phloroglucinol administered
time frame: baseline (minute 0)
measure: Quantity of (posology) phloroglucinol administered
time frame: 30 minutes
measure: Quantity of (posology) phloroglucinol administered
time frame: 90 minutes
measure: Quantity of (posology) phloroglucinol administered
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Was morphine administered? yes/no
time frame: baseline (minute 0)
measure: Quantity of (posology) morphine administered
time frame: 30 minutes
measure: Quantity of (posology) morphine administered
time frame: 90 minutes
measure: Quantity of (posology) morphine administered
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) Nefopam administered
time frame: baseline (minute 0)
measure: Quantity of (posology) Nefopam administered
time frame: 30 minutes
measure: Quantity of (posology) Nefopam administered
time frame: 90 minutes
measure: Quantity of (posology) Nefopam administered
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) Alfuzosine administered
time frame: baseline (minute 0)
measure: Quantity of (posology) Alfuzosine administered
time frame: 30 minutes
measure: Quantity of (posology) Alfuzosine administered
time frame: 90 minutes
measure: Quantity of (posology) Alfuzosine administered
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Presence/absence of complications
time frame: baseline (minute 0)
description: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
measure: Presence/absence of complications
time frame: 30 minutes
description: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
measure: Presence/absence of complications
time frame: 90 minutes
description: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
measure: Presence/absence of complications
time frame: week 1
description: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
measure: Was the patient hospitalized? yes/no
time frame: discharge from emergency ward (estimated max of 24 hours)
measure: Was the patient hospitalized? yes/no
time frame: week 1
measure: VNS for patient satisfaction concerning care
time frame: week 1
measure: Evolution towards a complicated renal colic
time frame: discharge from emergency ward (estimated max of 24 hours)
description: Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death
measure: Evolution towards a complicated renal colic
time frame: week 1
description: Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death
arm group label: Ketaprofen
arm group type: Active Comparator
description: Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.
Intervention: intravenous ketaprofen
arm group label: Paracetamol
arm group type: Experimental
description: Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.
Intervention: intravenous paracetamol
intervention type: Drug
intervention name: Intravenous ketoprofen
description: Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
arm group label: Ketaprofen
intervention type: Drug
intervention name: Intravenous paracetamol
description: Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)
arm group label: Paracetamol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Géraud Claret, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nîmes
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Colic
mesh term: Emergencies
mesh term: Renal Colic
mesh term: Acetaminophen
mesh term: Ketoprofen