<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/NCT01699815</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00036568</org_study_id>
    <nct_id>NCT01699815</nct_id>
  </id_info>
  <brief_title>Time of Intravenous Acetaminophen Administration</brief_title>
  <acronym>TIAA</acronym>
  <official_title>Time of Intravenous Acetaminophen Administration for Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the effects of timing of administration of intravenous&#xD;
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative&#xD;
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled&#xD;
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)&#xD;
      the pre-closure group will receive the first dose administered upon onset of skin closure, 2)&#xD;
      the preemptive group will receive the first dose administered within 60 minutes prior to&#xD;
      incision. Both groups will receive subsequent doses every 6 hours x 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to examine the effects of timing of administration of intravenous&#xD;
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative&#xD;
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled&#xD;
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)&#xD;
      the closure group will receive the first dose of one gram of intravenous acetaminophen&#xD;
      administered upon onset of skin closure, 2) the preemptive group will receive the first dose&#xD;
      of one gram of intravenous acetaminophen administered within 60 minutes prior to incision.&#xD;
      Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6&#xD;
      hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to&#xD;
      FDA recommendations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Postoperative Pain Scores</measure>
    <time_frame>preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug</time_frame>
    <description>To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Medication Consumption Rates</measure>
    <time_frame>Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug</time_frame>
    <description>Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Average Length of Stay (LOS)</measure>
    <time_frame>Baseline to discharge (1-4 days)</time_frame>
    <description>To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Preemptive group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Closure group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <arm_group_label>Closure group</arm_group_label>
    <arm_group_label>Preemptive group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip&#xD;
             arthroplasty performed under general anesthesia will be included. As determined by the&#xD;
             anesthesia team assigned to the case, eligible patients will also be assigned ASA&#xD;
             physical status of I, II, or III and deemed capable of reporting their perceived pain&#xD;
             using numeric pain scales and capable of operating a patient controlled anesthesia&#xD;
             (PCA) device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include known allergy, hypersensitivity, or contraindication to&#xD;
             acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients&#xD;
             with chronic malnutrition or a body mass index (BMI) &lt; 18 kg/m2 and non-English&#xD;
             speaking patients. Additional exclusion criteria include impaired liver function&#xD;
             defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine&#xD;
             &gt;2.0 mg/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia C Muckler, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham Regional Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>August 6, 2014</results_first_submitted>
  <results_first_submitted_qc>August 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 22, 2014</results_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acetaminophen</keyword>
  <keyword>timing</keyword>
  <keyword>arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Preemptive Group</title>
          <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.&#xD;
Acetaminophen</description>
        </group>
        <group group_id="P2">
          <title>Closure Group</title>
          <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>record could not be located</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Preemptive Group</title>
          <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.&#xD;
Acetaminophen</description>
        </group>
        <group group_id="B2">
          <title>Closure Group</title>
          <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</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="57"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="113"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.5" lower_limit="37" upper_limit="74"/>
                    <measurement group_id="B2" value="61.7" lower_limit="35" upper_limit="75"/>
                    <measurement group_id="B3" value="61.1" lower_limit="35" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_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="32"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Postoperative Pain Scores</title>
        <description>To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain</description>
        <time_frame>preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Preemptive Group</title>
            <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.&#xD;
Acetaminophen</description>
          </group>
          <group group_id="O2">
            <title>Closure Group</title>
            <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Postoperative Pain Scores</title>
          <description>To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain</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="57"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preoperatively (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.41"/>
                    <measurement group_id="O2" value="2.5" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PACU arrival (2-3 hour)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.3"/>
                    <measurement group_id="O2" value="1.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hrs post study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="2.75"/>
                    <measurement group_id="O2" value="2.6" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hrs post study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="2.69"/>
                    <measurement group_id="O2" value="2.3" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 hrs post study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.45"/>
                    <measurement group_id="O2" value="2.6" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hrs post study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.53"/>
                    <measurement group_id="O2" value="2.9" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Medication Consumption Rates</title>
        <description>Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.</description>
        <time_frame>Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Preemptive Group</title>
            <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.&#xD;
Acetaminophen</description>
          </group>
          <group group_id="O2">
            <title>Closure Group</title>
            <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Medication Consumption Rates</title>
          <description>Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Average Length of Stay (LOS)</title>
        <description>To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.</description>
        <time_frame>Baseline to discharge (1-4 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Preemptive Group</title>
            <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.&#xD;
Acetaminophen</description>
          </group>
          <group group_id="O2">
            <title>Closure Group</title>
            <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</description>
          </group>
        </group_list>
        <measure>
          <title>Average Length of Stay (LOS)</title>
          <description>To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.5"/>
                    <measurement group_id="O2" value="2.0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Preemptive Group</title>
          <description>The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.&#xD;
Acetaminophen</description>
        </group>
        <group group_id="E2">
          <title>Closure Group</title>
          <description>The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.&#xD;
Acetaminophen</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </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>
    <point_of_contact>
      <name_or_title>Virginia C. Muckler</name_or_title>
      <organization>Duke University School of Nursing</organization>
      <phone>919-684-9307</phone>
      <email>chris.muckler@duke.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/NCT01699815
org study id: Pro00036568
nct id: NCT01699815
lead sponsor: 
has dmc: Yes
The purpose of the study is to examine the effects of timing of administration of intravenous
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)
      the pre-closure group will receive the first dose administered upon onset of skin closure, 2)
      the preemptive group will receive the first dose administered within 60 minutes prior to
      incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
The purpose of the study is to examine the effects of timing of administration of intravenous
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)
      the closure group will receive the first dose of one gram of intravenous acetaminophen
      administered upon onset of skin closure, 2) the preemptive group will receive the first dose
      of one gram of intravenous acetaminophen administered within 60 minutes prior to incision.
      Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6
      hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to
      FDA recommendations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in Postoperative Pain Scores
time frame: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug
description: To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain
measure: Pain Medication Consumption Rates
time frame: Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug
description: Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.
measure: Average Length of Stay (LOS)
time frame: Baseline to discharge (1-4 days)
description: To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.
arm group label: Preemptive group
arm group type: Active Comparator
description: The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
arm group label: Closure group
arm group type: Active Comparator
description: The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
intervention type: Drug
intervention name: Acetaminophen
arm group label: Closure group
arm group label: Preemptive group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Virginia C Muckler, DNP
role: Principal Investigator
affiliation: Duke Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Acetaminophen
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 