<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/NCT01721486</url>
  </required_header>
  <id_info>
    <org_study_id>2012-162</org_study_id>
    <nct_id>NCT01721486</nct_id>
  </id_info>
  <brief_title>Acetaminophen's Efficacy For Post-operative Pain</brief_title>
  <official_title>Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaveh Aslani, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain&#xD;
      control in children undergoing tonsillectomy with or without adenoidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and&#xD;
      adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction,&#xD;
      the procedure can result in significant post-operative pain. Common analgesic techniques&#xD;
      include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such&#xD;
      as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has&#xD;
      been shown to be effective in reducing pain and post-operative opioid requirements. Its&#xD;
      administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain&#xD;
      control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are&#xD;
      effective for pain control but increase the risk of nausea and vomiting. They also have the&#xD;
      potential to cause respiratory depression.&#xD;
&#xD;
      IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an&#xD;
      adjunct to opioids for severe pain. Several studies have examined the efficacy of IV&#xD;
      acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR),&#xD;
      tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though&#xD;
      there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of&#xD;
      acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the&#xD;
      efficacy of oral vs IV administration for pain control post-tonsillectomy in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Pain Medication</measure>
    <time_frame>From time of PACU admission until 24 hours post-operatively.</time_frame>
    <description>All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FLACC: Face, Legs, Activity, Cry &amp; Consolability (FLACC) Pain Assessment Scores</measure>
    <time_frame>At time of admission into PACU.</time_frame>
    <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Post-operative Vomiting</measure>
    <time_frame>From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.</time_frame>
    <description>Percentage of subjects with at least one episode of post-operative vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Satisfaction With Pain Control.</measure>
    <time_frame>24 hours post hospital discharge.</time_frame>
    <description>Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Tonsillitis</condition>
  <condition>Airway Obstruction</condition>
  <condition>Difficulty Swallowing</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV acetaminophen</intervention_name>
    <description>IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Ofirmev</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PO acetaminophen</intervention_name>
    <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Acetaminophen Elixir</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 5-13 years of age&#xD;
&#xD;
          -  Surgical procedure: tonsillectomy with or without adenoidectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1 and 2 (patients&#xD;
             that have either no systemic illness or mild systemic disease that is well-controlled,&#xD;
             e.g. mild asthma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to study medication(s)&#xD;
&#xD;
          -  Known genetic abnormality&#xD;
&#xD;
          -  Known hepatitis&#xD;
&#xD;
          -  Children with other physical, mental or medical conditions which, in the opinion of&#xD;
             the PI, make study participation inadvisable or impairs pain assessment&#xD;
&#xD;
          -  Children who have taken any analgesic within 24 hours prior to surgery&#xD;
&#xD;
          -  Enrollment in concurrent research study&#xD;
&#xD;
          -  Pregnant patients*&#xD;
&#xD;
          -  Students/trainees/staff*&#xD;
&#xD;
          -  Mentally disabled/cognitively impaired*&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaveh Aslani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>June 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2017</results_first_posted>
  <last_update_submitted>June 6, 2017</last_update_submitted>
  <last_update_submitted_qc>June 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Kaveh Aslani, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>tonsillitis</keyword>
  <keyword>recurrent tonsillitis</keyword>
  <keyword>obstructed air passages</keyword>
  <keyword>swallowing difficulties</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Airway Obstruction</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>
      <recruitment_details>Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Study Group</title>
          <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.&#xD;
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.&#xD;
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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>
      <population>Baseline participant number does not include 2 patients removed from study.</population>
      <group_list>
        <group group_id="B1">
          <title>Study Group</title>
          <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.&#xD;
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.&#xD;
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.</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="20"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 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>
                  <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="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Pain Medication</title>
        <description>All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.</description>
        <time_frame>From time of PACU admission until 24 hours post-operatively.</time_frame>
        <population>Only patients receiving rescue pain medication were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Pain Medication</title>
          <description>All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.</description>
          <population>Only patients receiving rescue pain medication were analyzed.</population>
          <units>mg</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="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0" upper_limit="5.5"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FLACC: Face, Legs, Activity, Cry &amp; Consolability (FLACC) Pain Assessment Scores</title>
        <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
        <time_frame>At time of admission into PACU.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.</description>
          </group>
        </group_list>
        <measure>
          <title>FLACC: Face, Legs, Activity, Cry &amp; Consolability (FLACC) Pain Assessment Scores</title>
          <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Post-operative Vomiting</title>
        <description>Percentage of subjects with at least one episode of post-operative vomiting</description>
        <time_frame>From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-operative Vomiting</title>
          <description>Percentage of subjects with at least one episode of post-operative vomiting</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parental Satisfaction With Pain Control.</title>
        <description>Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.</description>
        <time_frame>24 hours post hospital discharge.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.</description>
          </group>
        </group_list>
        <measure>
          <title>Parental Satisfaction With Pain Control.</title>
          <description>Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.</description>
          <units>units on a scale</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="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="8" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Group</title>
          <description>IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.&#xD;
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.&#xD;
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </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="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>vomit x1</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>vomit x2</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>vomit x3</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>PACU delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>poss. airway swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>coughing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>stridor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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>The number of participants in both groups are very small. Data in pain scores outcome was skewed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kaveh Aslani, MD</name_or_title>
      <organization>Beaumont Hsopital</organization>
      <phone>248-898-1907</phone>
      <email>kaveh.aslani@beaumont.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/NCT01721486
org study id: 2012-162
nct id: NCT01721486
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain
      control in children undergoing tonsillectomy with or without adenoidectomy.
Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and
      adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction,
      the procedure can result in significant post-operative pain. Common analgesic techniques
      include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such
      as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has
      been shown to be effective in reducing pain and post-operative opioid requirements. Its
      administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain
      control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are
      effective for pain control but increase the risk of nausea and vomiting. They also have the
      potential to cause respiratory depression.

      IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an
      adjunct to opioids for severe pain. Several studies have examined the efficacy of IV
      acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR),
      tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though
      there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of
      acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the
      efficacy of oral vs IV administration for pain control post-tonsillectomy in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Total Pain Medication
time frame: From time of PACU admission until 24 hours post-operatively.
description: All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
measure: FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
time frame: At time of admission into PACU.
description: FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
measure: Incidence of Post-operative Vomiting
time frame: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.
description: Percentage of subjects with at least one episode of post-operative vomiting
measure: Parental Satisfaction With Pain Control.
time frame: 24 hours post hospital discharge.
description: Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.
arm group label: Study Group
arm group type: Experimental
description: IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
arm group label: Control Group
arm group type: Active Comparator
description: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
intervention type: Drug
intervention name: IV acetaminophen
description: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .
arm group label: Study Group
other name: Ofirmev
intervention type: Drug
intervention name: PO acetaminophen
description: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
arm group label: Control Group
other name: Acetaminophen Elixir
criteria: 
gender: All
minimum age: 5 Years
maximum age: 13 Years
healthy volunteers: No
last name: Kaveh Aslani, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Kaveh Aslani, MD
investigator title: Principal Investigator
mesh term: Tonsillitis
mesh term: Deglutition Disorders
mesh term: Airway Obstruction
mesh term: Acetaminophen
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The number of participants in both groups are very small. Data in pain scores outcome was skewed.
point of contact: 