<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/NCT02994173</url>
  </required_header>
  <id_info>
    <org_study_id>T281/2016</org_study_id>
    <nct_id>NCT02994173</nct_id>
  </id_info>
  <brief_title>Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients</brief_title>
  <acronym>DoseRespKeta</acronym>
  <official_title>Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku 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>
      To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous&#xD;
      patient-controlled analgesia bolus dosing and effects in patients scheduled for&#xD;
      posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 3, 2019</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 opioid consumption (mg) postoperatively</measure>
    <time_frame>24 and 72 hours</time_frame>
    <description>Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in numerical rating scale (NRS 0-10)</measure>
    <time_frame>24 and 72 hours</time_frame>
    <description>Change from baseline NRS value postoperatively at 24 and 72 hours</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxycodone 1 mg / ml alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine 0.25</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine 0.5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine 0.75</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Current clinical practice, used as a control in this study</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Oxanest</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-Ketamine 0.25</intervention_name>
    <description>dosage</description>
    <arm_group_label>Ketamine 0.25</arm_group_label>
    <other_name>Ketanest-S</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-Ketamine 0.5</intervention_name>
    <description>dosage</description>
    <arm_group_label>Ketamine 0.5</arm_group_label>
    <other_name>Ketanest-S</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-Ketamine 0.75</intervention_name>
    <description>dosage</description>
    <arm_group_label>Ketamine 0.75</arm_group_label>
    <other_name>Ketanest-S</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 - 75 years of age&#xD;
&#xD;
          -  Scheduled for elective posterolateral lumbar spine fusion with bilateral&#xD;
             transpedicular screw instrumentation under general anaesthesia.&#xD;
&#xD;
          -  Written informed consent from the participating patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A previous history of intolerance to the study drug or related compounds and additives&#xD;
&#xD;
          -  Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or&#xD;
             inhibitor(s) 2 weeks prior to study.&#xD;
&#xD;
          -  Patients younger than 20 years and older than 75 years.&#xD;
&#xD;
          -  BMI &gt; 35, sleep apnoea, any other sleep disorder or condition that requires treatment&#xD;
             with continuous positive airway pressure or automatic positive airway pressure device.&#xD;
&#xD;
          -  Existing significant liver or kidney disease&#xD;
&#xD;
          -  History of ischemic heart disease or conduction disturbance&#xD;
&#xD;
          -  History of alcoholism, drug abuse, psychological or other emotional problems that are&#xD;
             likely to invalidate informed consent&#xD;
&#xD;
          -  Donation of blood for 4 weeks prior and during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marko Peltoniemi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</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>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Esketamine</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/NCT02994173
org study id: T281/2016
nct id: NCT02994173
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous
      patient-controlled analgesia bolus dosing and effects in patients scheduled for
      posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in opioid consumption (mg) postoperatively
time frame: 24 and 72 hours
description: Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
measure: Change in numerical rating scale (NRS 0-10)
time frame: 24 and 72 hours
description: Change from baseline NRS value postoperatively at 24 and 72 hours
arm group label: Placebo
arm group type: Active Comparator
description: Oxycodone 1 mg / ml alone
arm group label: Ketamine 0.25
arm group type: Active Comparator
description: Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
arm group label: Ketamine 0.5
arm group type: Active Comparator
description: Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
arm group label: Ketamine 0.75
arm group type: Active Comparator
description: Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
intervention type: Drug
intervention name: Oxycodone
description: Current clinical practice, used as a control in this study
arm group label: Placebo
other name: Oxanest
intervention type: Drug
intervention name: S-Ketamine 0.25
description: dosage
arm group label: Ketamine 0.25
other name: Ketanest-S
intervention type: Drug
intervention name: S-Ketamine 0.5
description: dosage
arm group label: Ketamine 0.5
other name: Ketanest-S
intervention type: Drug
intervention name: S-Ketamine 0.75
description: dosage
arm group label: Ketamine 0.75
other name: Ketanest-S
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marko Peltoniemi, MD, PhD
role: Principal Investigator
affiliation: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Ketamine
mesh term: Oxycodone
mesh term: Esketamine
sharing ipd: No