<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/NCT03780556</url>
  </required_header>
  <id_info>
    <org_study_id>ASU 5418</org_study_id>
    <nct_id>NCT03780556</nct_id>
  </id_info>
  <brief_title>Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic</brief_title>
  <official_title>Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and&#xD;
      Group P administered pethidine and VAS was recorded for both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized, double blind clinical study including 120 patients with acute renal&#xD;
      pain admitted in emergency department. They were randomly assigned to one of two groups using&#xD;
      a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine&#xD;
      and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0,&#xD;
      15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing:&#xD;
      patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue&#xD;
      analgesia, adverse events and functional status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain feeling</measure>
    <time_frame>0hours, 1hour,2hours,3hours,4hours after drug administration in both groups</time_frame>
    <description>We assess this through Visual analogue scale score to assess pain due to renal colic, number 10 means maximum pain feeling and 0 means no pain at all.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>No need for more analgesics</measure>
    <time_frame>Registration of analgesic needed for 12h after the attack</time_frame>
    <description>Rescue analgesics administration</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Renal Colic</condition>
  <arm_group>
    <arm_group_label>Lornixicam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received lornoxicam 8 mg intravenous to control pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pethidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received pethidine 50mg intravenous to control pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lornoxicam and mepridine</intervention_name>
    <description>compare the effect of each to control pain</description>
    <arm_group_label>Lornixicam</arm_group_label>
    <arm_group_label>Pethidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, who did not administer any analgesics at least within the last two hours. -&#xD;
             -&#xD;
&#xD;
          -  Patients aged between 20-60 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous renal surgery&#xD;
&#xD;
          -  liver and renal failure&#xD;
&#xD;
          -  hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,&#xD;
&#xD;
          -  gastrointestinal bleeding and perforation,&#xD;
&#xD;
          -  hypertensive and history of cardiac diseases&#xD;
&#xD;
          -  pregnancy and lactation and&#xD;
&#xD;
          -  urine examination showing more than 5 leukocytes suggestive of pyuria.&#xD;
&#xD;
          -  patients with hyperthyroidism are excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ِAin Shams University hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Renal pain</keyword>
  <keyword>lornoxicam</keyword>
  <keyword>pethidine</keyword>
  <keyword>emergency room</keyword>
  <keyword>ketamine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</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>Lornoxicam</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/NCT03780556
org study id: ASU 5418
nct id: NCT03780556
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and
      Group P administered pethidine and VAS was recorded for both groups.
Prospective, randomized, double blind clinical study including 120 patients with acute renal
      pain admitted in emergency department. They were randomly assigned to one of two groups using
      a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine
      and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0,
      15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing:
      patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue
      analgesia, adverse events and functional status.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in pain feeling
time frame: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
description: We assess this through Visual analogue scale score to assess pain due to renal colic, number 10 means maximum pain feeling and 0 means no pain at all.
measure: No need for more analgesics
time frame: Registration of analgesic needed for 12h after the attack
description: Rescue analgesics administration
arm group label: Lornixicam
arm group type: Active Comparator
description: Patients received lornoxicam 8 mg intravenous to control pain
arm group label: Pethidine
arm group type: Active Comparator
description: Patients received pethidine 50mg intravenous to control pain
intervention type: Drug
intervention name: Lornoxicam and mepridine
description: compare the effect of each to control pain
arm group label: Lornixicam
arm group label: Pethidine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Colic
mesh term: Renal Colic
mesh term: Lornoxicam
sharing ipd: No