<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/NCT03783702</url>
  </required_header>
  <id_info>
    <org_study_id>46384</org_study_id>
    <nct_id>NCT03783702</nct_id>
  </id_info>
  <brief_title>Pain Control Following Sinus Surgery</brief_title>
  <official_title>Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NorthShore University HealthSystem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given the ongoing national opioid epidemic, an increased interest has developed in optimizing&#xD;
      opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus&#xD;
      surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over&#xD;
      250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to&#xD;
      the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids&#xD;
      to patients recovering from ESS). It has been shown that these excess opioid medications&#xD;
      contribute to prolonged use or abuse by the patient, family members, or friends. The purpose&#xD;
      of this study is to better understand the pain management requirements of patients who&#xD;
      undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).&#xD;
&#xD;
      This prospective, randomized, multi-institutional controlled trial will aim to determine the&#xD;
      degree to which pain following ESS can be adequately controlled by non-opioid medications. It&#xD;
      will also determine whether post-ESS narcotic use can be avoided entirely, or at least&#xD;
      significantly limited. Patients will be randomized into two groups, each of which will&#xD;
      receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or&#xD;
      acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and&#xD;
      the Brief Pain Inventory (BPI).&#xD;
&#xD;
      The results of this study will help to develop a standardized approach to pain management in&#xD;
      the post-ESS setting and help to elucidate the role of non-opioid pain medications. The&#xD;
      ultimate goal would be to positively affect opioid prescribing patterns among surgeons who&#xD;
      perform ESS in order to significantly reduce the quantity of opioids prescribed to patients&#xD;
      while continuing to adequately manage patients' pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>
    <intervention_model_description>Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for preoperative visit (the day before surgery)</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score was collected for postoperative day 1</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 2</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 3</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 4</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 5</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 6</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Average pain score will be collected for postoperative day 7</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication Log</measure>
    <time_frame>Postoperative day 1 to 7</time_frame>
    <description>Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>BPI score will be collected at the preoperative visit</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 1</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 2</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 3</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 4</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 5</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 6</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Score</measure>
    <time_frame>Average BPI score will be collected for postoperative day 7</time_frame>
    <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected at the preoperative visit</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 1</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 2</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 3</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 4</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 5</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 6</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Epistaxis</measure>
    <time_frame>Epistaxis severity will be collected for postoperative day 7</time_frame>
    <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Sinusitis</condition>
  <condition>Opioid Use</condition>
  <condition>Opioid Abuse</condition>
  <condition>Narcotic Use</condition>
  <condition>Otolaryngologic Disease</condition>
  <condition>Postoperative Pain</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OxyCODONE 5 Mg (milligram) Oral Tablet</intervention_name>
    <description>Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen 600 Mg (milligram) Oral Tablet</intervention_name>
    <description>Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen 650 MG (milligram) Oral Tablet</intervention_name>
    <description>All patients will receive acetaminophen as the first-line analgesic.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)&#xD;
&#xD;
          -  Can commit to follow up for at least one postoperative visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also&#xD;
        undergo sinus surgery)&#xD;
&#xD;
          -  Doyle splints to be used&#xD;
&#xD;
          -  Alcohol or opioid use disorder&#xD;
&#xD;
          -  History of chronic pain disorders&#xD;
&#xD;
          -  Regular use of acetaminophen/NSAIDS (&gt;4x per week)&#xD;
&#xD;
          -  Patients who use narcotics or neuromodulating drugs (e.g. gabapentin,&#xD;
             nortriptyline)more than 2x per week on average.&#xD;
&#xD;
          -  Gastrointestinal ulcers or bleeding&#xD;
&#xD;
          -  Chronic kidney disease/known decreased renal function (estimated glomerular filtration&#xD;
             rate &lt;60)&#xD;
&#xD;
          -  Liver cirrhosis or other hepatic impairment&#xD;
&#xD;
          -  Prior adverse reaction to opioids or NSAIDS&#xD;
&#xD;
          -  Other contraindications to any drug classes in either group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.</citation>
    <PMID>20058315</PMID>
  </reference>
  <reference>
    <citation>Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.</citation>
    <PMID>29460670</PMID>
  </reference>
  <reference>
    <citation>Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.</citation>
    <PMID>29446449</PMID>
  </reference>
  <reference>
    <citation>Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.</citation>
    <PMID>29557264</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <results_first_submitted>July 16, 2021</results_first_submitted>
  <results_first_submitted_qc>August 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2021</results_first_posted>
  <last_update_submitted>August 7, 2021</last_update_submitted>
  <last_update_submitted_qc>August 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Peter Hwang</investigator_full_name>
    <investigator_title>Principal Investigator, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Otorhinolaryngologic Diseases</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>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03783702/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</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="49"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.3" spread="16.1"/>
                    <measurement group_id="B2" value="43.3" spread="15.9"/>
                    <measurement group_id="B3" value="46.7" spread="16.3"/>
                  </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="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior sinus surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lund-mackay score</title>
          <description>The Lund-Mackay scoring system is a validated categorical scale used to define the extent of sinonasal disease on CT. The bilateral maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinuses are scored from 0-2, with 0 correlating to a normal sinus, 1 to partial opacification, and 2 to a fully opacified sinus. The bilateral ostiomeatal complexes are scored 0 if patent or 2 if obstructed. The total score ranges from 0 to 24, with 24 representing the most extensive disease.&#xD;
Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg 1997; 117:S35-40.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.7" spread="4.8"/>
                    <measurement group_id="B2" value="11.4" spread="5.9"/>
                    <measurement group_id="B3" value="10.5" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total baseline SNOT-22 score</title>
          <description>The SNOT-22 is a validated, disease-specific questionnaire in which patients report the presence and severity of 22 commonly experienced symptoms and social consequences of chronic rhinosinusitis over the prior 2-week period. Each question scales from 0 to 5, with 0 indicating &quot;no problem&quot; and 5 &quot;problem as bad as it can be.&quot; The highest possible score is 110, corresponding to the most severe symptoms.&#xD;
Hopkins C, Gillett S, Black R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol 2009; 34:447-54.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.6" spread="20.1"/>
                    <measurement group_id="B2" value="41.4" spread="19.8"/>
                    <measurement group_id="B3" value="40.5" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for preoperative visit (the day before surgery)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="20.0"/>
                    <measurement group_id="O2" value="8.5" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score was collected for postoperative day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2" spread="26.6"/>
                    <measurement group_id="O2" value="29.4" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="24.8"/>
                    <measurement group_id="O2" value="23.5" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="22.6"/>
                    <measurement group_id="O2" value="22.5" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="18.7"/>
                    <measurement group_id="O2" value="16.8" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="21.8"/>
                    <measurement group_id="O2" value="15.0" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" spread="19.0"/>
                    <measurement group_id="O2" value="11.7" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
        <time_frame>Average pain score will be collected for postoperative day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no pain&quot; with a score of 0 to &quot;worst imaginable pain,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="9.8"/>
                    <measurement group_id="O2" value="10.1" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medication Log</title>
        <description>Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.</description>
        <time_frame>Postoperative day 1 to 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Log</title>
          <description>Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.</description>
          <units>Average number of medication doses/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Oxycodone POD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.7"/>
                    <measurement group_id="O2" value="0.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.2"/>
                    <measurement group_id="O2" value="0.3" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                    <measurement group_id="O2" value="0.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxycodone POD7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.2"/>
                    <measurement group_id="O2" value="0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.5"/>
                    <measurement group_id="O2" value="2.1" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.4"/>
                    <measurement group_id="O2" value="1.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.3"/>
                    <measurement group_id="O2" value="1.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.5"/>
                    <measurement group_id="O2" value="1.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.2"/>
                    <measurement group_id="O2" value="1.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.3"/>
                    <measurement group_id="O2" value="1.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acetaminophen POD7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.0"/>
                    <measurement group_id="O2" value="0.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.9"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.8"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.9"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.8"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.6"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen POD7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.5"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>BPI score will be collected at the preoperative visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="2.2"/>
                    <measurement group_id="O2" value="1.0" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="2.3"/>
                    <measurement group_id="O2" value="2.9" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="2.1"/>
                    <measurement group_id="O2" value="2.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.0"/>
                    <measurement group_id="O2" value="2.1" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.8"/>
                    <measurement group_id="O2" value="1.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.1"/>
                    <measurement group_id="O2" value="1.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.9"/>
                    <measurement group_id="O2" value="1.4" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Score</title>
        <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
        <time_frame>Average BPI score will be collected for postoperative day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Score</title>
          <description>The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its &quot;least,&quot; &quot;worst,&quot; &quot;average,&quot; and &quot;now.&quot; The score ranges from 0 to 10 (higher indicates more pain).&#xD;
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.7"/>
                    <measurement group_id="O2" value="1.4" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected at the preoperative visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3" spread="33.2"/>
                    <measurement group_id="O2" value="38.9" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="27.1"/>
                    <measurement group_id="O2" value="21.6" spread="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="22.0"/>
                    <measurement group_id="O2" value="12.9" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="15.2"/>
                    <measurement group_id="O2" value="11.8" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="20.1"/>
                    <measurement group_id="O2" value="7.8" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="11.6"/>
                    <measurement group_id="O2" value="6.6" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Epistaxis</title>
        <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
        <time_frame>Epistaxis severity will be collected for postoperative day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Epistaxis</title>
          <description>A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from &quot;no bleeding&quot; with a score of 0 to &quot;continuous bleeding,&quot; corresponding to a score of 100.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="9.2"/>
                    <measurement group_id="O2" value="5.4" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the one week period after surgery for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics&#xD;
rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours&#xD;
nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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>
    <limitations_and_caveats>The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use&#xD;
Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up&#xD;
Lack of blinding and placebo were additional limitations</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Noel Ayoub</name_or_title>
      <organization>Stanford University School of Medicine</organization>
      <phone>3109407055</phone>
      <email>nfa@stanford.edu</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/NCT03783702
org study id: 46384
nct id: NCT03783702
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Given the ongoing national opioid epidemic, an increased interest has developed in optimizing
      opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus
      surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over
      250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to
      the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids
      to patients recovering from ESS). It has been shown that these excess opioid medications
      contribute to prolonged use or abuse by the patient, family members, or friends. The purpose
      of this study is to better understand the pain management requirements of patients who
      undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

      This prospective, randomized, multi-institutional controlled trial will aim to determine the
      degree to which pain following ESS can be adequately controlled by non-opioid medications. It
      will also determine whether post-ESS narcotic use can be avoided entirely, or at least
      significantly limited. Patients will be randomized into two groups, each of which will
      receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or
      acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and
      the Brief Pain Inventory (BPI).

      The results of this study will help to develop a standardized approach to pain management in
      the post-ESS setting and help to elucidate the role of non-opioid pain medications. The
      ultimate goal would be to positively affect opioid prescribing patterns among surgeons who
      perform ESS in order to significantly reduce the quantity of opioids prescribed to patients
      while continuing to adequately manage patients' pain.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Severity
time frame: Average pain score will be collected for preoperative visit (the day before surgery)
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score was collected for postoperative day 1
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 2
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 3
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 4
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 5
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 6
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Pain Severity
time frame: Average pain score will be collected for postoperative day 7
description: A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
measure: Medication Log
time frame: Postoperative day 1 to 7
description: Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.
measure: Brief Pain Inventory (BPI) Score
time frame: BPI score will be collected at the preoperative visit
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 1
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 2
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 3
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 4
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 5
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 6
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Brief Pain Inventory (BPI) Score
time frame: Average BPI score will be collected for postoperative day 7
description: The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected at the preoperative visit
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 1
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 2
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 3
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 4
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 5
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 6
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
measure: Severity of Epistaxis
time frame: Epistaxis severity will be collected for postoperative day 7
description: A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
arm group label: Experimental group
arm group type: Experimental
description: Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.
arm group label: Control group
arm group type: Active Comparator
description: Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).
intervention type: Drug
intervention name: OxyCODONE 5 Mg (milligram) Oral Tablet
description: Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Ibuprofen 600 Mg (milligram) Oral Tablet
description: Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
arm group label: Experimental group
intervention type: Drug
intervention name: Acetaminophen 650 MG (milligram) Oral Tablet
description: All patients will receive acetaminophen as the first-line analgesic.
arm group label: Control group
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
citation: Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
PMID: 20058315
citation: Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.
PMID: 29460670
citation: Svider PF, Arianpour K, Guo E, Folbe E, Zuliani G, Lin H, Eloy JA, Folbe AJ. Opioid prescribing patterns among otolaryngologists: Crucial insights among the medicare population. Laryngoscope. 2018 Jul;128(7):1576-1581. doi: 10.1002/lary.27101. Epub 2018 Feb 15.
PMID: 29446449
citation: Mohan S, Bhattacharyya N. Opioids and the Otolaryngologist: An Ambulatory Assessment. Otolaryngol Head Neck Surg. 2018 Jul;159(1):29-34. doi: 10.1177/0194599818765125. Epub 2018 Mar 20.
PMID: 29557264
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Peter Hwang
investigator title: Principal Investigator, Professor
mesh term: Sinusitis
mesh term: Otorhinolaryngologic Diseases
mesh term: Opioid-Related Disorders
mesh term: Acetaminophen
mesh term: Ibuprofen
mesh term: Oxycodone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The low levels of narcotic consumption observed may have precluded achieving significance in pain score comparisons across groups, as the pre-hoc power analysis predicted higher levels of opioid use
Selection bias: 1) patient willingness to participate in an opioid-related study could serve as a source of bias 2) loss to follow up
Lack of blinding and placebo were additional limitations
point of contact: 