<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/NCT02968823</url>
  </required_header>
  <id_info>
    <org_study_id>1308/2016</org_study_id>
    <nct_id>NCT02968823</nct_id>
  </id_info>
  <brief_title>Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery</brief_title>
  <official_title>Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat (ENT) and Maxilla-Facial Surgery - A Randomized, Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</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>
      Our primary aim is to determine whether licorice gargling provides meaningful analgesia after&#xD;
      oral surgery. Specifically, we propose to test the primary hypothesis that gargling with&#xD;
      licorice solution reduces pain after oral surgery more than gargling with sugar water.&#xD;
      Because effective analgesia can reduce pain and/or opioid consumption, we will jointly&#xD;
      evaluate verbal response pain scores and overall morphine consumption considering licorice to&#xD;
      be beneficial only if it proves non-inferior on both measures and superior on at least one.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)</measure>
    <time_frame>first 2 postoperative hours</time_frame>
    <description>A joint outcome of average pain score and total opioid consumption between the end of surgery and the first two postoperative hours. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>joint - pain scores and opiate consumption on day of surgery</measure>
    <time_frame>from end of surgery until the morning of Post-Operative Day (POD) 1</time_frame>
    <description>Postoperative pain intensity and opioid consumption between the end of surgery and the first postoperative morning. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>joint - pain scores and analgesic consumption</measure>
    <time_frame>from surgery conclusion to Post-Operative Day (POD) 3</time_frame>
    <description>pain intensity and total analgesics (metamizole or mefenamic acid) consumption in the first three days after surgery. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative coughing</measure>
    <time_frame>first 2 postoperative hours</time_frame>
    <description>incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Surgery, Oral</condition>
  <arm_group>
    <arm_group_label>Licorice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Licorice gargle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugar gargle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Licorice</intervention_name>
    <description>ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3</description>
    <arm_group_label>Licorice</arm_group_label>
    <other_name>Extractum Liquiritiae Fluidum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sugar water</intervention_name>
    <description>Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3</description>
    <arm_group_label>Sugar water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Oropharyngeal surgeries including:Panendoscopic surgery; elective&#xD;
             tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma&#xD;
&#xD;
          2. Anticipated extubation in the operating room&#xD;
&#xD;
          3. American Society of Anesthesia physical status 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rapid Sequence Induction&#xD;
&#xD;
          2. Known or suspected allergy to licorice or its ingredients&#xD;
&#xD;
          3. Liver failure with bleeding disorders&#xD;
&#xD;
          4. Insulin-dependent diabetes mellitus&#xD;
&#xD;
          5. Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery&#xD;
&#xD;
          6. Chronic opioid use&#xD;
&#xD;
          7. Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump&#xD;
&#xD;
          8. superinfected oropharyngeal tumors&#xD;
&#xD;
          9. Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Plattner, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marita Windpassinger, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MUVienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Olga Plattner</investigator_full_name>
    <investigator_title>Ao. Univ. Prof., Head of ophthalmologic anesthesia</investigator_title>
  </responsible_party>
  <keyword>Postoperative Pain</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Oral Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT02968823
org study id: 1308/2016
nct id: NCT02968823
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our primary aim is to determine whether licorice gargling provides meaningful analgesia after
      oral surgery. Specifically, we propose to test the primary hypothesis that gargling with
      licorice solution reduces pain after oral surgery more than gargling with sugar water.
      Because effective analgesia can reduce pain and/or opioid consumption, we will jointly
      evaluate verbal response pain scores and overall morphine consumption considering licorice to
      be beneficial only if it proves non-inferior on both measures and superior on at least one.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)
time frame: first 2 postoperative hours
description: A joint outcome of average pain score and total opioid consumption between the end of surgery and the first two postoperative hours. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.
measure: joint - pain scores and opiate consumption on day of surgery
time frame: from end of surgery until the morning of Post-Operative Day (POD) 1
description: Postoperative pain intensity and opioid consumption between the end of surgery and the first postoperative morning. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.
measure: joint - pain scores and analgesic consumption
time frame: from surgery conclusion to Post-Operative Day (POD) 3
description: pain intensity and total analgesics (metamizole or mefenamic acid) consumption in the first three days after surgery. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.
measure: postoperative coughing
time frame: first 2 postoperative hours
description: incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU
arm group label: Licorice
arm group type: Active Comparator
description: Licorice gargle
arm group label: Sugar water
arm group type: Placebo Comparator
description: Sugar gargle
intervention type: Other
intervention name: Licorice
description: ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3
arm group label: Licorice
other name: Extractum Liquiritiae Fluidum
intervention type: Other
intervention name: Sugar water
description: Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3
arm group label: Sugar water
criteria: 
gender: All
minimum age: 12 Years
maximum age: 99 Years
healthy volunteers: No
last name: Olga Plattner, M.D.
role: Study Chair
affiliation: Medical University of Vienna
last name: Marita Windpassinger, M.D.
role: Principal Investigator
affiliation: Medical University Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Olga Plattner
investigator title: Ao. Univ. Prof., Head of ophthalmologic anesthesia
mesh term: Pain, Postoperative
sharing ipd: No