<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/NCT02252614</url>
  </required_header>
  <id_info>
    <org_study_id>DiskapiYBERH</org_study_id>
    <nct_id>NCT02252614</nct_id>
  </id_info>
  <brief_title>Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain</brief_title>
  <official_title>Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Yildirim Beyazit Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Yildirim Beyazit Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of&#xD;
      paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour&#xD;
      after a lumbar disk surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were treated using patient-controlled analgesia with contramal for 24 hours after a&#xD;
      lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein&#xD;
      or isotonic saline (placebo).&#xD;
&#xD;
      The primary endpoint was pain intensity measured by the visual analogue scale, and secondary&#xD;
      endpoints were contramal consumption and related side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity, contramal consumption</measure>
    <time_frame>Postoperative 24 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects, nausa, vomiting</measure>
    <time_frame>postoperative 24 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Postoperative Pain, PCA Contramal Consumption</condition>
  <arm_group>
    <arm_group_label>Naproxen sodium codein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol codein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>naproxen sodium codein</intervention_name>
    <description>Pain intensity, contramal consumption</description>
    <arm_group_label>Naproxen sodium codein</arm_group_label>
    <other_name>Apranax plus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol codein</intervention_name>
    <description>Pain intensity, contramal consumption</description>
    <arm_group_label>Paracetamol codein</arm_group_label>
    <other_name>Geralgine K tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pain intensity, contramal consumption</description>
    <arm_group_label>Placebo tablet</arm_group_label>
    <other_name>Placebo tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists 1 or 2 status patients scheduled for elective&#xD;
             lumbar disk surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients, known allergies to any of the drugs used in this study&#xD;
&#xD;
          -  eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to&#xD;
             provide informed consent (eg, mental disorders)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reyhan Polat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diskapi YBERH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reyhan Polat, MD</last_name>
    <phone>+905326734310</phone>
    <email>reyhanp9@gmail.com</email>
  </overall_contact>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Yildirim Beyazit Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Reyhan Polat</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>naproxen sodium+codein, paracetamol+codein,lumbar disc surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Naproxen</mesh_term>
    <mesh_term>Codeine</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/NCT02252614
org study id: DiskapiYBERH
nct id: NCT02252614
lead sponsor: 
has dmc: Yes
Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of
      paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour
      after a lumbar disk surgery.
Patients were treated using patient-controlled analgesia with contramal for 24 hours after a
      lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein
      or isotonic saline (placebo).

      The primary endpoint was pain intensity measured by the visual analogue scale, and secondary
      endpoints were contramal consumption and related side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pain intensity, contramal consumption
time frame: Postoperative 24 hour
measure: side effects, nausa, vomiting
time frame: postoperative 24 hour
arm group label: Naproxen sodium codein
arm group type: Active Comparator
description: Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
arm group label: Paracetamol codein
arm group type: Experimental
description: Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
arm group label: Placebo tablet
arm group type: Placebo Comparator
description: Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
intervention type: Drug
intervention name: naproxen sodium codein
description: Pain intensity, contramal consumption
arm group label: Naproxen sodium codein
other name: Apranax plus
intervention type: Drug
intervention name: paracetamol codein
description: Pain intensity, contramal consumption
arm group label: Paracetamol codein
other name: Geralgine K tablet
intervention type: Drug
intervention name: Placebo
description: Pain intensity, contramal consumption
arm group label: Placebo tablet
other name: Placebo tablet
criteria: 
gender: All
minimum age: 16 Years
maximum age: 90 Years
healthy volunteers: No
last name: Reyhan Polat, MD
role: Principal Investigator
affiliation: Diskapi YBERH
last name: Reyhan Polat, MD
phone: +905326734310
email: reyhanp9@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
investigator full name: Reyhan Polat
investigator title: Medical Doctor
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Naproxen
mesh term: Codeine