<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/NCT01708122</url>
  </required_header>
  <id_info>
    <org_study_id>13623-01</org_study_id>
    <secondary_id>UL1TR000124</secondary_id>
    <nct_id>NCT01708122</nct_id>
  </id_info>
  <brief_title>Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures</brief_title>
  <official_title>A Prospective, Randomized, Double Blind Study Comparing the Efficacy and Safety of Fentanyl Nasal Spray to Placebo as an Analgesic, in Patients Undergoing Outpatient Cystoscopic Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl&#xD;
      spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the&#xD;
      bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any&#xD;
      other problems with the urinary bladder). The current standard practice is to use Lidocaine&#xD;
      jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this&#xD;
      study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after&#xD;
      the above procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this double-blind study, a nasal spray of either the drug (fentanyl -- an opioid&#xD;
      analgesic) or placebo (normal saline) is administered before the procedure. There is a 50%&#xD;
      chance that patients receive the drug or the placebo. In either case, local Lidocaine jelly&#xD;
      is used as an anesthetic in the urethra. Each patient is compensated for time and traveling&#xD;
      after the completion of his/her participation.&#xD;
&#xD;
      Patients are asked to arrive between 7 and 11 PM on the evening prior to their procedure for&#xD;
      an overnight admission to 5 East ward, on the 5th floor of the Harbor UCLA Medical Center in&#xD;
      Torrance, California, United States. Once there, vital signs (blood pressure, pulse, oxygen&#xD;
      saturation -- amount of oxygen in the blood, and breathing rate) is checked and an&#xD;
      intravenous line is placed. Before, during and after the procedure, patients are asked to&#xD;
      rate their pain on a scale of 0 to 10 with 0 being &quot;no pain&quot; and 10 being &quot;the worst pain&#xD;
      possible.&quot;&#xD;
&#xD;
      Regardless of whether patients are assigned to receive fentanyl or placebo, they receive the&#xD;
      standard of care for this cystoscopic procedure.&#xD;
&#xD;
      Once in the cystoscopy room, patients receive the study drug by nasal (into the nose) spray.&#xD;
      The study drug is supplied in a pre-filled syringe that contains either 100 mcg of fentanyl&#xD;
      or placebo (normal saline with no active medicine in it). Once the study drug is given, the&#xD;
      vital signs are closely monitored(checked) until the effect of drug wears off, usually&#xD;
      between 2 and 4 hours.&#xD;
&#xD;
      Blood samples are drawn on several occasions. This blood is used to see how much of the study&#xD;
      drug (fentanyl or placebo) appears in the blood.&#xD;
&#xD;
      Adverse effects: The well-known adverse effects of opioids may occur after nasal as well as&#xD;
      conventional routes of administration; however, severe adverse effects such as respiratory&#xD;
      depression or hypotension do not seem to occur in any appreciable frequency.&#xD;
&#xD;
      Intranasal fentanyl has been used safely and effectively in many studies. There are no&#xD;
      reports of any serious side effects with the small dose (100 mcg) that is being used in this&#xD;
      study. Intranasal fentanyl is generally well tolerated with no serious adverse events. In&#xD;
      cancer patients treated for breakthrough pain, the main treatment related side effects were&#xD;
      nausea, vertigo, dizziness, constipation, and somnolence. For local side effects, fentanyl&#xD;
      displays little local irritation, nasal discomfort or taste experiences. Nasal irritation,&#xD;
      skin pain, nasal mucosa ulcers and dysgeusia have been occasionally reported as minor side&#xD;
      effects.&#xD;
&#xD;
      The following minor side effects have been reported with other forms of fentanyl (oral, patch&#xD;
      or intravenous): anxiety; confusion; difficulty walking; dizziness; drowsiness; dry mouth;&#xD;
      headache; itching; nausea and vomiting.&#xD;
&#xD;
      The following severe side effects have not been reported with intranasal fentanyl but have&#xD;
      been reported with other forms of fentanyl (oral, patch or intravenous): allergic reactions&#xD;
      (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face,&#xD;
      lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue;&#xD;
      hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat;&#xD;
      respiratory depression or slowed breathing; trouble breathing and feeling of weakness.&#xD;
&#xD;
      Advantages to patients: If effective, less pain during and after the cystoscopic procedure&#xD;
      and better tolerance of the procedure.&#xD;
&#xD;
      Advantages to humanity: If effective, nasal fentanyl could be used as a means to reduce pain&#xD;
      before and during cystoscopic procedures.&#xD;
&#xD;
      These benefits may not happen and unexpected side effects may develop.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre Procedure 0 - 10 Pain Numerical Rating Scale</measure>
    <time_frame>Pre procedure, During procedure, Post procedure</time_frame>
    <description>The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:&#xD;
1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>O2 Saturation Post Drug Administration</measure>
    <time_frame>Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.</time_frame>
    <description>After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>100 mcg in 1 mL intranasal spray</description>
    <arm_group_label>Fentanyl</arm_group_label>
    <other_name>fentanyl citrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>Sodium Chloride 0.9% intranasal spray</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Urological indications for cystoscopic procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of analgesia abuse or former opioid addiction.&#xD;
&#xD;
          2. Allergy to fentanyl.&#xD;
&#xD;
          3. Acute/chronic nasal problems such as rhinitis or sinusitis.&#xD;
&#xD;
          4. Positive urine pregnancy test / lactation.&#xD;
&#xD;
          5. Acute bronchial asthma / upper airway obstruction.&#xD;
&#xD;
          6. Presence of bradycardia or a history of seizures.&#xD;
&#xD;
          7. Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole,&#xD;
             itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir,&#xD;
             aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and&#xD;
             verapamil)&#xD;
&#xD;
          8. 0-10 NRS pain score more than 3 on baseline.&#xD;
&#xD;
          9. Any situation or condition which, in the investigator's opinion, puts the subject at&#xD;
             significant risk, or could confound the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Reznichek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harbor UCLA Medical Center Urology Clinic</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>March 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>July 25, 2015</results_first_submitted>
  <results_first_submitted_qc>July 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 20, 2015</results_first_posted>
  <last_update_submitted>July 25, 2015</last_update_submitted>
  <last_update_submitted_qc>July 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</investigator_affiliation>
    <investigator_full_name>Richard C Reznichek, MD</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Intranasal fentanyl</keyword>
  <keyword>Cystoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Seventy-one patients agreed to participate in the study and signed informed consent. Nine patients declined to proceed. Seven did not pass pre-anesthesia screening due to pre-existing medical conditions. Cystoscopic procedures were deemed no longer indicated for two patients. Ultimately, 53 patients were randomized and completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Subjects will receive 0.1 mL of intranasal saline as placebo.&#xD;
saline: Sodium Chloride 0.9% intranasal spray</description>
        </group>
        <group group_id="P2">
          <title>Fentanyl</title>
          <description>Subjects receiving either 50mcg or 100mcg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fentanyl</title>
          <description>Subjects will receive 50 to 100 mcg intranasal fentanyl&#xD;
Fentanyl: 100 mcg in 1 mL intranasal spray</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Subjects will receive intranasal saline as placebo.&#xD;
Saline: Sodium Chloride 0.9% intranasal spray</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.2" lower_limit="21" upper_limit="65"/>
                    <measurement group_id="B2" value="47.1" lower_limit="29" upper_limit="74"/>
                    <measurement group_id="B3" value="46.2" lower_limit="21" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pre Procedure 0 - 10 Pain Numerical Rating Scale</title>
        <description>The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:&#xD;
1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.</description>
        <time_frame>Pre procedure, During procedure, Post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fentanyl</title>
            <description>Subjects will receive 50 to 100 mcg intranasal fentanyl&#xD;
Fentanyl: 100 mcg in 1 mL intranasal spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects will receive intranasal saline as placebo.&#xD;
Saline: Sodium Chloride 0.9% intranasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>Pre Procedure 0 - 10 Pain Numerical Rating Scale</title>
          <description>The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:&#xD;
1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.</description>
          <units>0 - 10 Pain Numerical Rating Scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>O2 Saturation Post Drug Administration</title>
        <description>After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.</description>
        <time_frame>Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fentanyl</title>
            <description>Subjects will receive 50 to 100 mcg intranasal fentanyl&#xD;
Fentanyl: 100 mcg in 1 mL intranasal spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects will receive intranasal saline as placebo.&#xD;
Saline: Sodium Chloride 0.9% intranasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>O2 Saturation Post Drug Administration</title>
          <description>After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.</description>
          <units>percentage of O2 Saturation</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="99.3" lower_limit="96" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O2" value="99.3" lower_limit="96" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O2" value="99.4" lower_limit="96" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="99.4" lower_limit="96" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From administration of study drug until 3 hours post administration</time_frame>
      <desc>By direct questioning regarding the presence of the following: Nasal Irritation, nausea, vomiting, dizziness, respiratory distress, confusion, headache, dry mouth and any other discomfort no related to the surgical procedure with the possible answers yes or no. Subject can also report spontaneously during their stay in the department.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fentanyl</title>
          <description>Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)&#xD;
Fentanyl: 100 mcg in 1 mL intranasal spray</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.&#xD;
Saline: Sodium Chloride 0.9% intranasal spray</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Irritation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Richard Reznichek</name_or_title>
      <organization>Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Urology</organization>
      <phone>3102222724</phone>
      <email>RReznichek@dhs.lacounty.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01708122
org study id: 13623-01
secondary id: UL1TR000124
nct id: NCT01708122
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl
      spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the
      bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any
      other problems with the urinary bladder). The current standard practice is to use Lidocaine
      jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this
      study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after
      the above procedure.
In this double-blind study, a nasal spray of either the drug (fentanyl -- an opioid
      analgesic) or placebo (normal saline) is administered before the procedure. There is a 50%
      chance that patients receive the drug or the placebo. In either case, local Lidocaine jelly
      is used as an anesthetic in the urethra. Each patient is compensated for time and traveling
      after the completion of his/her participation.

      Patients are asked to arrive between 7 and 11 PM on the evening prior to their procedure for
      an overnight admission to 5 East ward, on the 5th floor of the Harbor UCLA Medical Center in
      Torrance, California, United States. Once there, vital signs (blood pressure, pulse, oxygen
      saturation -- amount of oxygen in the blood, and breathing rate) is checked and an
      intravenous line is placed. Before, during and after the procedure, patients are asked to
      rate their pain on a scale of 0 to 10 with 0 being "no pain" and 10 being "the worst pain
      possible."

      Regardless of whether patients are assigned to receive fentanyl or placebo, they receive the
      standard of care for this cystoscopic procedure.

      Once in the cystoscopy room, patients receive the study drug by nasal (into the nose) spray.
      The study drug is supplied in a pre-filled syringe that contains either 100 mcg of fentanyl
      or placebo (normal saline with no active medicine in it). Once the study drug is given, the
      vital signs are closely monitored(checked) until the effect of drug wears off, usually
      between 2 and 4 hours.

      Blood samples are drawn on several occasions. This blood is used to see how much of the study
      drug (fentanyl or placebo) appears in the blood.

      Adverse effects: The well-known adverse effects of opioids may occur after nasal as well as
      conventional routes of administration; however, severe adverse effects such as respiratory
      depression or hypotension do not seem to occur in any appreciable frequency.

      Intranasal fentanyl has been used safely and effectively in many studies. There are no
      reports of any serious side effects with the small dose (100 mcg) that is being used in this
      study. Intranasal fentanyl is generally well tolerated with no serious adverse events. In
      cancer patients treated for breakthrough pain, the main treatment related side effects were
      nausea, vertigo, dizziness, constipation, and somnolence. For local side effects, fentanyl
      displays little local irritation, nasal discomfort or taste experiences. Nasal irritation,
      skin pain, nasal mucosa ulcers and dysgeusia have been occasionally reported as minor side
      effects.

      The following minor side effects have been reported with other forms of fentanyl (oral, patch
      or intravenous): anxiety; confusion; difficulty walking; dizziness; drowsiness; dry mouth;
      headache; itching; nausea and vomiting.

      The following severe side effects have not been reported with intranasal fentanyl but have
      been reported with other forms of fentanyl (oral, patch or intravenous): allergic reactions
      (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face,
      lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue;
      hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat;
      respiratory depression or slowed breathing; trouble breathing and feeling of weakness.

      Advantages to patients: If effective, less pain during and after the cystoscopic procedure
      and better tolerance of the procedure.

      Advantages to humanity: If effective, nasal fentanyl could be used as a means to reduce pain
      before and during cystoscopic procedures.

      These benefits may not happen and unexpected side effects may develop.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pre Procedure 0 - 10 Pain Numerical Rating Scale
time frame: Pre procedure, During procedure, Post procedure
description: The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:
1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed.
measure: O2 Saturation Post Drug Administration
time frame: Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.
description: After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.
arm group label: Fentanyl
arm group type: Experimental
description: Subjects will receive either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive either 0.5mL or 1 mL of intranasal saline as placebo.
intervention type: Drug
intervention name: Fentanyl
description: 100 mcg in 1 mL intranasal spray
arm group label: Fentanyl
other name: fentanyl citrate
intervention type: Drug
intervention name: saline
description: Sodium Chloride 0.9% intranasal spray
arm group label: Placebo
other name: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Reznichek, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
investigator full name: Richard C Reznichek, MD
investigator title: Medical Doctor
mesh term: Fentanyl
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 