<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/NCT02244619</url>
  </required_header>
  <id_info>
    <org_study_id>KMCPH-13-001</org_study_id>
    <nct_id>NCT02244619</nct_id>
  </id_info>
  <brief_title>PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement</brief_title>
  <acronym>KHEA</acronym>
  <official_title>Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kettering Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kettering Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip&#xD;
      or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV&#xD;
      acetaminophen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to receive perioperative dosing of either:&#xD;
&#xD;
        1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,&#xD;
&#xD;
        2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).&#xD;
&#xD;
      Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Post-operative Use of Opioids</measure>
    <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
    <description>Post-operative use of opioids, measured in morphine milligram equivalent (MME) units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-rated Pain in the Post-operative Period</measure>
    <time_frame>Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery</time_frame>
    <description>Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Post-operative Nausea and Vomiting</measure>
    <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time to First Ambulation - 10 Feet</measure>
    <time_frame>During post-op period up to 24 hours after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time to First Rescue Opioid (PRN Order)</measure>
    <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">515</enrollment>
  <condition>Post-op Pain</condition>
  <arm_group>
    <arm_group_label>Oral acetaminophen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV acetaminophen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral acetaminophen</intervention_name>
    <description>Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
    <arm_group_label>Oral acetaminophen</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV acetaminophen</intervention_name>
    <description>Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
    <arm_group_label>IV acetaminophen</arm_group_label>
    <other_name>Ofirmev</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Weighing over 50 kg&#xD;
&#xD;
          -  Will undergo total hip or total knee joint replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-verbal patients&#xD;
&#xD;
          -  Unable to use numeric pain scale&#xD;
&#xD;
          -  Allergic to the test article&#xD;
&#xD;
          -  Documented hepatic impairment or failure&#xD;
&#xD;
          -  Current illicit drug use&#xD;
&#xD;
          -  Requires traumatic or emergent surgery&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Women who are breastfeeding&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of&#xD;
             Attorney (POA)&#xD;
&#xD;
          -  Unable to swallow oral capsules&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sidney (Skip) Hickman, RPh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kettering Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>May 17, 2017</results_first_submitted>
  <results_first_submitted_qc>July 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2017</results_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip replacement</keyword>
  <keyword>Knee replacement</keyword>
  <keyword>randomized trial</keyword>
  <keyword>acetaminophen</keyword>
  <keyword>post-op pain management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Acetaminophen</title>
          <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
        </group>
        <group group_id="P2">
          <title>IV Acetaminophen</title>
          <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
                <participants group_id="P2" count="266"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
                <participants group_id="P2" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not receive study intervention</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Acetaminophen</title>
          <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
        </group>
        <group group_id="B2">
          <title>IV Acetaminophen</title>
          <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</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="241"/>
            <count group_id="B2" value="245"/>
            <count group_id="B3" value="486"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.0" lower_limit="59.5" upper_limit="73.0"/>
                    <measurement group_id="B2" value="67.0" lower_limit="60.0" upper_limit="72.5"/>
                    <measurement group_id="B3" value="67.0" lower_limit="60.0" upper_limit="73.0"/>
                  </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="148"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="240"/>
                    <measurement group_id="B3" value="477"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </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="3"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="234"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="464"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Taking medications for chronic pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="212"/>
                    <measurement group_id="B3" value="426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oxford score (hip or knee as appropriate)</title>
          <description>12-item ordinal scales. Each item ranges from 0 (high impairment) to 4 (no impairment). Total score ranges from 0-48 with following interpretation:&#xD;
0-19: May indicate severe arthritis.&#xD;
20-29: May indicate moderate to severe arthritis.&#xD;
30-39: May indicate mild to moderate arthritis.&#xD;
40-48: May indicate satisfactory joint function.</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="20.76" spread="7.5"/>
                    <measurement group_id="B2" value="20.19" spread="7.8"/>
                    <measurement group_id="B3" value="20.47" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <description>In the study data, BMI ranged from 19 (minimum) to 56 (maximum).</description>
          <units>lb/in^2x703</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.9" lower_limit="28.3" upper_limit="37.08"/>
                    <measurement group_id="B2" value="32.3" lower_limit="28.5" upper_limit="36.71"/>
                    <measurement group_id="B3" value="32.1" lower_limit="28.4" upper_limit="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Knee</title>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="338"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hip</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative opioid</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative Celecoxib</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="195"/>
                    <measurement group_id="B3" value="393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative Pregabalin</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                    <measurement group_id="B2" value="232"/>
                    <measurement group_id="B3" value="462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intra-operative total opioid</title>
          <units>morphine milligram equivalents (MME)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.0" lower_limit="6.7" upper_limit="16.7"/>
                    <measurement group_id="B2" value="10.0" lower_limit="6.7" upper_limit="15.0"/>
                    <measurement group_id="B3" value="10.0" lower_limit="6.7" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intra-operative Ketorolac</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intra-operative Bupivacaine Liposome Injectable Suspension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                    <measurement group_id="B2" value="162"/>
                    <measurement group_id="B3" value="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Post-operative Use of Opioids</title>
        <description>Post-operative use of opioids, measured in morphine milligram equivalent (MME) units</description>
        <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Post-operative Use of Opioids</title>
          <description>Post-operative use of opioids, measured in morphine milligram equivalent (MME) units</description>
          <units>Morphine milligram equivalents (MME)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="12.5" upper_limit="33.6"/>
                    <measurement group_id="O2" value="21.7" lower_limit="11.3" upper_limit="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-rated Pain in the Post-operative Period</title>
        <description>Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.</description>
        <time_frame>Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-rated Pain in the Post-operative Period</title>
          <description>Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.</description>
          <units>Visual analog pain scale (0-10)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.4" upper_limit="5.0"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2.1" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Post-operative Nausea and Vomiting</title>
        <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Nausea and Vomiting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to First Ambulation - 10 Feet</title>
        <time_frame>During post-op period up to 24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Ambulation - 10 Feet</title>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" lower_limit="13.8" upper_limit="21.3"/>
                    <measurement group_id="O2" value="18.8" lower_limit="15.1" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to First Rescue Opioid (PRN Order)</title>
        <time_frame>During post-op period up to 24 hrs after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Rescue Opioid (PRN Order)</title>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" lower_limit="20.5" upper_limit="151.0"/>
                    <measurement group_id="O2" value="41.0" lower_limit="19.0" upper_limit="151.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Post-Anesthesia Care Unit (PACU) Length of Stay, Hours</title>
        <description>PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.</description>
        <time_frame>PACU admission time until PACU discharge time</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Anesthesia Care Unit (PACU) Length of Stay, Hours</title>
          <description>PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.</description>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.7" upper_limit="2.7"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.7" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Hospital Length of Stay (LOS)</title>
        <description>Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.</description>
        <time_frame>Pre-op admission to hospital discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Acetaminophen</title>
            <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
          <group group_id="O2">
            <title>IV Acetaminophen</title>
            <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay (LOS)</title>
          <description>Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.</description>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0" lower_limit="55.6" upper_limit="79.6"/>
                    <measurement group_id="O2" value="58.5" lower_limit="55.5" upper_limit="80.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE/SAE monitoring started at first study drug dose and ended when subjects were discharged from the Post-Anesthesia Care Unit. The time period varied among subjects but was never more than 24 hours total.</time_frame>
      <desc>Since both the PO and IV forms of the study drug are FDA approved, both are being used within approved labeling, and the study is not being conducted under an Investigational New Drug (IND) application, only events that meet Kettering Health Network's criteria for reporting within the institution's S.A.F.E. reporting system will be reported as SAEs or UPs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Acetaminophen</title>
          <description>Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.&#xD;
Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.</description>
        </group>
        <group group_id="E2">
          <title>IV Acetaminophen</title>
          <description>Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.&#xD;
IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.</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="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </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="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Skip Hickman, RPH</name_or_title>
      <organization>Kettering Health Network</organization>
      <phone>(937) 762-1339</phone>
      <email>skip.hickman@ketteringhealth.org</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/NCT02244619
org study id: KMCPH-13-001
nct id: NCT02244619
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip
      or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV
      acetaminophen
Subjects will be randomized to receive perioperative dosing of either:

        1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,

        2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).

      Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Total Post-operative Use of Opioids
time frame: During post-op period up to 24 hrs after surgery
description: Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
measure: Patient-rated Pain in the Post-operative Period
time frame: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
description: Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.
measure: Post-operative Nausea and Vomiting
time frame: During post-op period up to 24 hrs after surgery
measure: Time to First Ambulation - 10 Feet
time frame: During post-op period up to 24 hours after surgery
measure: Time to First Rescue Opioid (PRN Order)
time frame: During post-op period up to 24 hrs after surgery
arm group label: Oral acetaminophen
arm group type: Active Comparator
description: Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
arm group label: IV acetaminophen
arm group type: Active Comparator
description: Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
intervention type: Drug
intervention name: Oral acetaminophen
description: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
arm group label: Oral acetaminophen
other name: Tylenol
intervention type: Drug
intervention name: IV acetaminophen
description: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
arm group label: IV acetaminophen
other name: Ofirmev
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sidney (Skip) Hickman, RPh
role: Principal Investigator
affiliation: Kettering Health Network
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acetaminophen
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.
point of contact: 