<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/NCT03295214</url>
  </required_header>
  <id_info>
    <org_study_id>1098410</org_study_id>
    <nct_id>NCT03295214</nct_id>
  </id_info>
  <brief_title>Acetaminophen Given Per Os and Intravenous in Sinus Surgery</brief_title>
  <official_title>A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts Eye and Ear Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts Eye and Ear Infirmary</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>
      The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain&#xD;
      within the post-operative setting and determine if there is a statistically significant&#xD;
      difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the&#xD;
      investigators can produce the maximal amount of pain relief after surgery while making&#xD;
      conscientious monetary decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat&#xD;
      Surgeries done in the United States annually. This procedure can vary from intense to&#xD;
      moderate pain and as such it is difficult to properly gauge and treat postoperative pain in&#xD;
      these patients. Commonly used in these cases, opioid drugs are given to provide adequate&#xD;
      analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care&#xD;
      Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV).&#xD;
      Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid&#xD;
      sparing properties.&#xD;
&#xD;
      Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter.&#xD;
      Its properties include analgesic and antipyretic qualities and it is listed on the world&#xD;
      health organization's list of essential medicines. The potential risks include liver damage,&#xD;
      skin reactions and drug interactions when used with blood thinners at high doses.&#xD;
      Acetaminophen has been extensively researched, in vitro and in vivo studies have found the&#xD;
      drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has&#xD;
      gained popularity due to ease of use and ability to be given intraoperatively. This form of&#xD;
      acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen.&#xD;
      Due to this increased cost it is imperative that the investigators compare the two routes of&#xD;
      administration in order to determine if the additional cost is justified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 3</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS for pain</measure>
    <time_frame>0-1 hour</time_frame>
    <description>First VAS pain score applied</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative opioid consumption for pain control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in PACU</measure>
    <time_frame>3-5 hours</time_frame>
    <description>Time required to be admitted and discharged home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS for pain</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Second VAS pain score applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS for pain</measure>
    <time_frame>2-3 hours</time_frame>
    <description>Third VAS pain score applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS for pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Last VAS pain score applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV</measure>
    <time_frame>24 hours</time_frame>
    <description>Incidence of PONV</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Acetaminophen</condition>
  <arm_group>
    <arm_group_label>Acetaminophen 975mg Per Os</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>975mg of Acetaminophen given by mouth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetaminophen 1000mg Intravenous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1000mg of Acetaminophen given intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen given for pain relief</description>
    <arm_group_label>Acetaminophen 1000mg Intravenous</arm_group_label>
    <arm_group_label>Acetaminophen 975mg Per Os</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate&#xD;
&#xD;
          -  Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)&#xD;
&#xD;
          -  Over the age of 18 during time of surgery&#xD;
&#xD;
          -  Weighing over 50kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hepatic impairment or active liver disease&#xD;
&#xD;
          -  Known hypersensitivity to acetaminophen or to any excipients in the intravenous&#xD;
             formulation&#xD;
&#xD;
          -  chronic opioid use&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  alcohol or drug abuse&#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>Iuliu Fat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MEEI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Quinkert, PhD</last_name>
    <phone>6175734192</phone>
    <email>amy_quinkert@meei.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iuliu Fat, MD</last_name>
    <phone>617-573-3380</phone>
    <email>iuliu_fat@meei.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brendan McBrine, BS</last_name>
      <phone>617-573-6815</phone>
      <email>brendan_mcbrine@meei.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.</citation>
    <PMID>7986507</PMID>
  </reference>
  <reference>
    <citation>DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.</citation>
    <PMID>9428860</PMID>
  </reference>
  <reference>
    <citation>Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.</citation>
    <PMID>23220855</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
    <investigator_full_name>Luliu Fat</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acetaminophen</keyword>
  <keyword>Functional Endoscopic Sinus Surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</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/NCT03295214
org study id: 1098410
nct id: NCT03295214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain
      within the post-operative setting and determine if there is a statistically significant
      difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the
      investigators can produce the maximal amount of pain relief after surgery while making
      conscientious monetary decisions.
Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat
      Surgeries done in the United States annually. This procedure can vary from intense to
      moderate pain and as such it is difficult to properly gauge and treat postoperative pain in
      these patients. Commonly used in these cases, opioid drugs are given to provide adequate
      analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care
      Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV).
      Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid
      sparing properties.

      Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter.
      Its properties include analgesic and antipyretic qualities and it is listed on the world
      health organization's list of essential medicines. The potential risks include liver damage,
      skin reactions and drug interactions when used with blood thinners at high doses.
      Acetaminophen has been extensively researched, in vitro and in vivo studies have found the
      drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has
      gained popularity due to ease of use and ability to be given intraoperatively. This form of
      acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen.
      Due to this increased cost it is imperative that the investigators compare the two routes of
      administration in order to determine if the additional cost is justified.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: VAS for pain
time frame: 0-1 hour
description: First VAS pain score applied
measure: Opioid Use
time frame: 24 hours
description: Postoperative opioid consumption for pain control
measure: Time in PACU
time frame: 3-5 hours
description: Time required to be admitted and discharged home
measure: VAS for pain
time frame: 1-2 hours
description: Second VAS pain score applied
measure: VAS for pain
time frame: 2-3 hours
description: Third VAS pain score applied
measure: VAS for pain
time frame: 24 hours
description: Last VAS pain score applied
measure: PONV
time frame: 24 hours
description: Incidence of PONV
arm group label: Acetaminophen 975mg Per Os
arm group type: Active Comparator
description: 975mg of Acetaminophen given by mouth
arm group label: Acetaminophen 1000mg Intravenous
arm group type: Active Comparator
description: 1000mg of Acetaminophen given intravenously
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen given for pain relief
arm group label: Acetaminophen 1000mg Intravenous
arm group label: Acetaminophen 975mg Per Os
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iuliu Fat, MD
role: Principal Investigator
affiliation: MEEI
last name: Amy Quinkert, PhD
phone: 6175734192
email: amy_quinkert@meei.harvard.edu
last name: Iuliu Fat, MD
phone: 617-573-3380
email: iuliu_fat@meei.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.
PMID: 7986507
citation: DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.
PMID: 9428860
citation: Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.
PMID: 23220855
responsible party type: Principal Investigator
investigator affiliation: Massachusetts Eye and Ear Infirmary
investigator full name: Luliu Fat
investigator title: Principal Investigator
mesh term: Acetaminophen
sharing ipd: No