<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/NCT02243254</url>
  </required_header>
  <id_info>
    <org_study_id>ibuprofen_hyperalgesia</org_study_id>
    <nct_id>NCT02243254</nct_id>
  </id_info>
  <brief_title>Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      Postoperative hyperalgesia has been reported after intraoperative administration of small or&#xD;
      high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the&#xD;
      development of opioid-induced hyperalgesia. The aim of this study is to evaluate the&#xD;
      preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">April 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cumulative morphine consumption</measure>
    <time_frame>postoperative 48 hours</time_frame>
    <description>cumulative patient-controlled analgesia (PCA) morphine consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 1, 3, 6,12, 24, 48 hours Pain score</time_frame>
    <description>visual analogue scale</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Ibuprofen</condition>
  <condition>Remifentanil</condition>
  <condition>Hyperalgesia</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>high dose remifentanil without ibuprofen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose remifentanil without ibuprofen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose remifentanil with ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose remifentanil with ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high dose remifentanil</intervention_name>
    <description>high dose remifentanil</description>
    <arm_group_label>high dose remifentanil with ibuprofen</arm_group_label>
    <arm_group_label>high dose remifentanil without ibuprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>intravenous ibuprofen</description>
    <arm_group_label>high dose remifentanil with ibuprofen</arm_group_label>
    <arm_group_label>low dose remifentanil with ibuprofen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low dose remifentanil</intervention_name>
    <description>low dose remifentanil</description>
    <arm_group_label>low dose remifentanil with ibuprofen</arm_group_label>
    <arm_group_label>low dose remifentanil without ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for elective pancreaticoduodenectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic pain&#xD;
&#xD;
          -  Patients with psychiatric disease&#xD;
&#xD;
          -  Patients with nonsteroidal antiinflammatory drugs allergy&#xD;
&#xD;
          -  Patients with renail dysfunction&#xD;
&#xD;
          -  History of drug addiction&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Inability to use a PCA device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 16, 2015</last_update_submitted>
  <last_update_submitted_qc>November 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2015</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>Hyperalgesia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Remifentanil</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/NCT02243254
org study id: ibuprofen_hyperalgesia
nct id: NCT02243254
lead sponsor: 
Postoperative hyperalgesia has been reported after intraoperative administration of small or
      high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the
      development of opioid-induced hyperalgesia. The aim of this study is to evaluate the
      preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: cumulative morphine consumption
time frame: postoperative 48 hours
description: cumulative patient-controlled analgesia (PCA) morphine consumption
measure: Pain score
time frame: postoperative 1, 3, 6,12, 24, 48 hours Pain score
description: visual analogue scale
arm group label: high dose remifentanil without ibuprofen
arm group type: Placebo Comparator
description: remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision
arm group label: low dose remifentanil without ibuprofen
arm group type: Placebo Comparator
description: remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision
arm group label: high dose remifentanil with ibuprofen
arm group type: Active Comparator
description: remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision
arm group label: low dose remifentanil with ibuprofen
arm group type: Active Comparator
description: remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision
intervention type: Drug
intervention name: high dose remifentanil
description: high dose remifentanil
arm group label: high dose remifentanil with ibuprofen
arm group label: high dose remifentanil without ibuprofen
intervention type: Drug
intervention name: Ibuprofen
description: intravenous ibuprofen
arm group label: high dose remifentanil with ibuprofen
arm group label: low dose remifentanil with ibuprofen
intervention type: Drug
intervention name: low dose remifentanil
description: low dose remifentanil
arm group label: low dose remifentanil with ibuprofen
arm group label: low dose remifentanil without ibuprofen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperalgesia
mesh term: Pain, Postoperative
mesh term: Ibuprofen
mesh term: Remifentanil