<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/NCT03822962</url>
  </required_header>
  <id_info>
    <org_study_id>0417-18-FB</org_study_id>
    <nct_id>NCT03822962</nct_id>
  </id_info>
  <brief_title>Pain Management Following Sinus Surgery</brief_title>
  <official_title>Post-operative Pain Management Following Functional Endoscopic Sinus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the&#xD;
      post-operative pain management of sinus surgery patients and wether or not this addition&#xD;
      reduces or eliminates the need for narcotic pain medications.&#xD;
&#xD;
      Patients will be instructed to take an NSAID regimen after surgery and will be instructed to&#xD;
      take narcotics only for breakthrough pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      National attention has been given to the concerning rise of opioid abuse in this country,&#xD;
      with prescriptions for this medications more than quadrupaling in the last 17 years.&#xD;
&#xD;
      Little is known as to the appropriate use of opioid analgesics in the post-operative recovery&#xD;
      of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol&#xD;
      based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol&#xD;
      based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid&#xD;
      analgesics.&#xD;
&#xD;
      This study will compare opioid use with and without the addition of NSAIDS following sinus&#xD;
      surgery.&#xD;
&#xD;
      Post-operative opioid use is a great public health concern, relatively unstudied, and an area&#xD;
      with an opportunity for potential intervention to significantly reduce risks, morbidity, and&#xD;
      mortality to our postoperative patients by better formulating a postoperative pain management&#xD;
      plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the&#xD;
      risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative&#xD;
      pain management protocols, the need for opioids following sinus surgery should be minimized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decrease in accrual during the COVID-19 pandemic and several sites withdrawing&#xD;
  </why_stopped>
  <start_date type="Actual">November 7, 2020</start_date>
  <completion_date type="Actual">May 30, 2023</completion_date>
  <primary_completion_date type="Actual">May 30, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective, cohort study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain level</measure>
    <time_frame>1 week</time_frame>
    <description>Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication.&#xD;
The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding</measure>
    <time_frame>1 week</time_frame>
    <description>Any physician visits secondary to bleeding will be tabulated including ER and office visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Nasal Sinus; Inflammation</condition>
  <condition>Opioid Abuse</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Standard Tylenol Regimen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will be given a standard regimen:&#xD;
Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen 600mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen 600Mg Tablet</intervention_name>
    <description>ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.</description>
    <arm_group_label>Ibuprofen 600mg</arm_group_label>
    <other_name>Advil, Motrin IB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Regimen | Tylenol</intervention_name>
    <description>Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.</description>
    <arm_group_label>Ibuprofen 600mg</arm_group_label>
    <arm_group_label>Standard Tylenol Regimen</arm_group_label>
    <other_name>Acetaminophen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway&#xD;
        surgery (septoplasty and/or inferior turbinate reduction).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not taking anti-coagulation medications including aspirin&#xD;
&#xD;
          -  Clinical Diagnosis of aspirin-exacerbated respiratory disease&#xD;
&#xD;
          -  Clinical Diagnosis of Cystic Fibrosis&#xD;
&#xD;
          -  Clinical Diagnosis of Primary Ciliary Dyskinesia&#xD;
&#xD;
          -  Inclusion of a Draf III frontal sinusotomy&#xD;
&#xD;
          -  Clinical Diagnosis of Liver/Kidney Failure&#xD;
&#xD;
          -  Clinical Diagnosis of Thrombocytopenia&#xD;
&#xD;
          -  Clinical Diagnosis of Poorly controlled hypertension&#xD;
&#xD;
          -  Clinical Diagnosis of Recent GI ulcers or gastritis&#xD;
&#xD;
          -  Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months&#xD;
             or involvement in a pain management program&#xD;
&#xD;
          -  Clinical Diagnosis of Primary Headache disorder&#xD;
&#xD;
          -  The use of nasal decongestants in the post-operative period.&#xD;
&#xD;
          -  The use of nasal packing or absorbable biomaterials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christie Barnes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</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 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSAIDs</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>post-operative hemorrhage</keyword>
  <keyword>Functional endoscopic sinus surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</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/NCT03822962
org study id: 0417-18-FB
nct id: NCT03822962
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the
      post-operative pain management of sinus surgery patients and wether or not this addition
      reduces or eliminates the need for narcotic pain medications.

      Patients will be instructed to take an NSAID regimen after surgery and will be instructed to
      take narcotics only for breakthrough pain.
National attention has been given to the concerning rise of opioid abuse in this country,
      with prescriptions for this medications more than quadrupaling in the last 17 years.

      Little is known as to the appropriate use of opioid analgesics in the post-operative recovery
      of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol
      based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol
      based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid
      analgesics.

      This study will compare opioid use with and without the addition of NSAIDS following sinus
      surgery.

      Post-operative opioid use is a great public health concern, relatively unstudied, and an area
      with an opportunity for potential intervention to significantly reduce risks, morbidity, and
      mortality to our postoperative patients by better formulating a postoperative pain management
      plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the
      risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative
      pain management protocols, the need for opioids following sinus surgery should be minimized.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: prospective, cohort study
primary purpose: Treatment
masking: None (Open Label)
measure: Pain level
time frame: 1 week
description: Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication.
The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.
measure: Rate of bleeding
time frame: 1 week
description: Any physician visits secondary to bleeding will be tabulated including ER and office visits.
arm group label: Standard Tylenol Regimen
arm group type: Other
description: Patient will be given a standard regimen:
Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
arm group label: Ibuprofen 600mg
arm group type: Active Comparator
description: Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
intervention type: Drug
intervention name: Ibuprofen 600Mg Tablet
description: ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
arm group label: Ibuprofen 600mg
other name: Advil, Motrin IB
intervention type: Other
intervention name: Standard Regimen | Tylenol
description: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
arm group label: Ibuprofen 600mg
arm group label: Standard Tylenol Regimen
other name: Acetaminophen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christie Barnes, MD
role: Principal Investigator
affiliation: University of Nebraska
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Inflammation
mesh term: Pain, Postoperative
mesh term: Opioid-Related Disorders
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: No