<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/NCT04412642</url>
  </required_header>
  <id_info>
    <org_study_id>431-2019</org_study_id>
    <nct_id>NCT04412642</nct_id>
  </id_info>
  <brief_title>Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures</brief_title>
  <official_title>Pilot Study to Assess the Feasibility of Self-administered Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The participant will be trained to self administer the drug and will be supplied with a&#xD;
      PENTHROX commercial inhaler kit .The study nurse will train the participant and supervise its&#xD;
      use during the procedure.Immediately following the procedure the participant will be asked to&#xD;
      fill out two brief questionnaires. The study nurse will assess the participant for adverse&#xD;
      event and will follow-up with a phone call 24 hours later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients with chronic urological conditions require multiple and sometimes painful&#xD;
      urological procedures. Ideally these procedures may be done in the cystoscopy suite without a&#xD;
      general anesthetic. Low dose methoxyflurane, (MEOF)is a inhaled, self-administered non-opioid&#xD;
      analgesic and has been approved by Health Canada's for the short-term relief of moderate to&#xD;
      severe acute pain, associated with trauma or international medical procedures, in conscious&#xD;
      adult patients. The brand name is PENTHROX.&#xD;
&#xD;
      This study is a single centre, pilot study to assess the feasibility of using a&#xD;
      self-administrated, MEOF for pain relief during minor out-patient urological procedures.&#xD;
      Eligible participants will receive a one time dose of the the study medication during a&#xD;
      planned, outpatient urological procedure done under cystoscopy in the Cystoscopy clinic&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 31, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge</measure>
    <time_frame>end of procedure</time_frame>
    <description>Global assessment of Medication,which is an assessment, performed by the patient, of the patient's impression of how well the medication works. The patient is asked to rate the pain relief given by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale</measure>
    <time_frame>during the procedure</time_frame>
    <description>Patient is asked to rate the intensity of the pain experienced using an 11-point numeric rating scale is used. A score of 0=no pain and a score of 10= worst pain possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent patients requiring rescue medication</measure>
    <time_frame>during the procedure</time_frame>
    <description>Documentation of the use of rescue medication post administration of methooxyflurane Documenting first time of use of rescue medication, type of medication administered,dose and route</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome measure to assess percentage of patients requiring rescue medication</measure>
    <time_frame>During the procedure;post procedure and at 24 hours post procedure (phone contact)</time_frame>
    <description>Documentation of adverse events as safety outcome measure by the health care professional</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge</measure>
    <time_frame>end of procedure</time_frame>
    <description>Global assessment of Medication Performance, is an assessment, performed by the health care professional, of their impression of how well the medication works. The health care professional is asked a single question &quot;rate the pain relief provided by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale</measure>
    <time_frame>end of procedure</time_frame>
    <description>The patient is asked a single question &quot;To what extent has your expectations regarding pain control been met?&quot;, using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of how well the medication fulfilled the health care professional's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale</measure>
    <time_frame>end of procedure</time_frame>
    <description>The health care professional is asked a single question &quot;To what extent has your expectations regarding pain control been met?&quot;, using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>methoxyflurane</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>methoxyflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methoxyflurane, MEOF</intervention_name>
    <description>As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.</description>
    <arm_group_label>methoxyflurane</arm_group_label>
    <other_name>Penthrox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Conscious adult patients &gt;=&#xD;
&#xD;
          2. Patient is scheduled for cystoscopy And:&#xD;
&#xD;
               -  BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity,&#xD;
&#xD;
               -  Diagnostic hydrodistention for painful bladder syndrome&#xD;
&#xD;
               -  Biopsy or cauterization of bladder tumors&#xD;
&#xD;
               -  Biopsy, cauterization and/or injection of Hunner's lesions&#xD;
&#xD;
               -  Visual urethrotomy/bladder neck incision=/- injection of stricture&#xD;
&#xD;
               -  Evaluation of the complex urinary tract problems&#xD;
&#xD;
          3. Patient (patient/or patient's authorization legal representative) should understand&#xD;
             the nature of the study and provide written informed consent&#xD;
&#xD;
          4. Patient is able to follow all study requirements and procedures and complete required&#xD;
             questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An altered level of consciousness, due to any cause, including head injury, drugs,or&#xD;
             alcohol&#xD;
&#xD;
          2. Clinically significant renal impairment&#xD;
&#xD;
          3. Women of child bearing potential who are pregnant or peri partum, including labour&#xD;
&#xD;
          4. A history of liver dysfunction after previous MEOF use or other halogenated&#xD;
             anesthetics&#xD;
&#xD;
          5. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated&#xD;
             hydroxytoluene&#xD;
&#xD;
          6. Known or genetically susceptible to malignant hyperthermia or a history of severe&#xD;
             adverse reactions in either patient or relatives&#xD;
&#xD;
          7. Exacerbation of an underlying condition (i.e., chronic pain)&#xD;
&#xD;
          8. Clinically evident or potential hemodynamic instability as per the opinion of the&#xD;
             investigator&#xD;
&#xD;
          9. Clinically evident respiratory impairment as per the opinion of the investigator&#xD;
&#xD;
         10. Prior treatment with PENTHROX within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Sender Herschorn, MD, FRSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joanne M Lawrence, RN,BSc.</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>2309</phone_ext>
    <email>joannelawrence@bell.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sender Herschorn, MD,FRSC</last_name>
    <phone>416-480-4733</phone>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</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>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methoxyflurane</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/NCT04412642
org study id: 431-2019
nct id: NCT04412642
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The participant will be trained to self administer the drug and will be supplied with a
      PENTHROX commercial inhaler kit .The study nurse will train the participant and supervise its
      use during the procedure.Immediately following the procedure the participant will be asked to
      fill out two brief questionnaires. The study nurse will assess the participant for adverse
      event and will follow-up with a phone call 24 hours later.
Many patients with chronic urological conditions require multiple and sometimes painful
      urological procedures. Ideally these procedures may be done in the cystoscopy suite without a
      general anesthetic. Low dose methoxyflurane, (MEOF)is a inhaled, self-administered non-opioid
      analgesic and has been approved by Health Canada's for the short-term relief of moderate to
      severe acute pain, associated with trauma or international medical procedures, in conscious
      adult patients. The brand name is PENTHROX.

      This study is a single centre, pilot study to assess the feasibility of using a
      self-administrated, MEOF for pain relief during minor out-patient urological procedures.
      Eligible participants will receive a one time dose of the the study medication during a
      planned, outpatient urological procedure done under cystoscopy in the Cystoscopy clinic
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking
measure: Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
time frame: end of procedure
description: Global assessment of Medication,which is an assessment, performed by the patient, of the patient's impression of how well the medication works. The patient is asked to rate the pain relief given by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
measure: The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
time frame: during the procedure
description: Patient is asked to rate the intensity of the pain experienced using an 11-point numeric rating scale is used. A score of 0=no pain and a score of 10= worst pain possible
measure: Percent patients requiring rescue medication
time frame: during the procedure
description: Documentation of the use of rescue medication post administration of methooxyflurane Documenting first time of use of rescue medication, type of medication administered,dose and route
measure: Safety outcome measure to assess percentage of patients requiring rescue medication
time frame: During the procedure;post procedure and at 24 hours post procedure (phone contact)
description: Documentation of adverse events as safety outcome measure by the health care professional
measure: Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
time frame: end of procedure
description: Global assessment of Medication Performance, is an assessment, performed by the health care professional, of their impression of how well the medication works. The health care professional is asked a single question "rate the pain relief provided by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
measure: Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
time frame: end of procedure
description: The patient is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
measure: Assessment of how well the medication fulfilled the health care professional's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
time frame: end of procedure
description: The health care professional is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
arm group label: methoxyflurane
arm group type: Other
description: methoxyflurane
intervention type: Drug
intervention name: Methoxyflurane, MEOF
description: As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
arm group label: methoxyflurane
other name: Penthrox
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sender Herschorn, MD, FRSC
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Joanne M Lawrence, RN,BSc.
phone: 416-480-6100
phone ext: 2309
email: joannelawrence@bell.net
last name: Sender Herschorn, MD,FRSC
phone: 416-480-4733
responsible party type: Sponsor
mesh term: Acute Pain
mesh term: Methoxyflurane