<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/NCT02252458</url>
  </required_header>
  <id_info>
    <org_study_id>2014-054</org_study_id>
    <nct_id>NCT02252458</nct_id>
  </id_info>
  <brief_title>Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?</brief_title>
  <acronym>FentaOIH-V</acronym>
  <official_title>Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether two clinically sensible dose regimen of&#xD;
      fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal&#xD;
      rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain&#xD;
      modalities tested will include transdermal electrical stimulation and cold pressor pain.&#xD;
&#xD;
      The investigators hypothesize that the high dose fentanyl group will have an increase of&#xD;
      approximately 20% in the NRS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.</measure>
    <time_frame>4.5 to 6.5h after begin of fentanyl infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain as measured by the nonverbal rating scale</measure>
    <time_frame>0-2h after begin of fentanyl infusion at 15 min intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cold pressor pain</measure>
    <time_frame>at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)</measure>
    <time_frame>-15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pupillary dilation response</measure>
    <time_frame>baseline and at 4.5h after begin of infusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fentanyl high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fentanyl 10mcg/kg of bodyweight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fentanyl 1mcg/kg of bodyweight</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <arm_group_label>Fentanyl high dose</arm_group_label>
    <arm_group_label>Fentanyl low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy (ASA I-II) male volunteers&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  BMI 18 - 25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers unable to give written informed consent&#xD;
&#xD;
          -  Known drug allergies or intolerance to fentanyl&#xD;
&#xD;
          -  Known drug allergies or intolerance to morphine and other opiates&#xD;
&#xD;
          -  Recreational drug addiction or abuse&#xD;
&#xD;
          -  Opiate use in the last month&#xD;
&#xD;
          -  Volunteers taking confounding medication (analgesics, antihistamines, calcium or&#xD;
             potassium channel blockers) in the last month&#xD;
&#xD;
          -  History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric&#xD;
             disease&#xD;
&#xD;
          -  Patients with renal failure (clearance &lt; 30 ml/min)&#xD;
&#xD;
          -  obstructive sleep apnea syndrome (OSAS)&#xD;
&#xD;
          -  Indication for Rapid Sequence Induction&#xD;
&#xD;
          -  Patients not understanding German, French, Italian or English&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilhelm Ruppen, PD Dr., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Basel, Dep. of Anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia, University of Basel Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 8, 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>January 8, 2015</last_update_submitted>
  <last_update_submitted_qc>January 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid induced hyperalgesia</keyword>
  <keyword>Fentanyl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperalgesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT02252458
org study id: 2014-054
nct id: NCT02252458
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine whether two clinically sensible dose regimen of
      fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal
      rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain
      modalities tested will include transdermal electrical stimulation and cold pressor pain.

      The investigators hypothesize that the high dose fentanyl group will have an increase of
      approximately 20% in the NRS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
time frame: 4.5 to 6.5h after begin of fentanyl infusion
measure: Pain as measured by the nonverbal rating scale
time frame: 0-2h after begin of fentanyl infusion at 15 min intervals
measure: cold pressor pain
time frame: at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion
measure: Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)
time frame: -15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion
measure: pupillary dilation response
time frame: baseline and at 4.5h after begin of infusion
arm group label: Fentanyl high dose
arm group type: Experimental
description: Fentanyl 10mcg/kg of bodyweight
arm group label: Fentanyl low dose
arm group type: Active Comparator
description: Fentanyl 1mcg/kg of bodyweight
intervention type: Drug
intervention name: Fentanyl
arm group label: Fentanyl high dose
arm group label: Fentanyl low dose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wilhelm Ruppen, PD Dr., MD
role: Principal Investigator
affiliation: University Hospital Basel, Dep. of Anesthesia
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hyperalgesia
mesh term: Fentanyl