<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/NCT02218424</url>
  </required_header>
  <id_info>
    <org_study_id>2014MagRCT</org_study_id>
    <nct_id>NCT02218424</nct_id>
  </id_info>
  <brief_title>Magnesium vs Placebo for Tonsillectomy</brief_title>
  <official_title>Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double-blind randomized controlled trial using intravenous magnesium versus&#xD;
      placebo to determine if systemic magnesium can decrease postoperative pain in pediatric&#xD;
      patients undergoing tonsillectomy.&#xD;
&#xD;
      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg&#xD;
      bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of&#xD;
      normal saline bolus followed by infusion (placebo).&#xD;
&#xD;
      The primary objective is to determine if systemic magnesium will decrease postoperative pain&#xD;
      in patients undergoing tonsillectomy. The secondary objectives will determine if systemic&#xD;
      magnesium administration is associated with a decrease in opioid-related side effects,&#xD;
      decrease the incidence of emergence delirium, and improve postoperative functional recovery.&#xD;
&#xD;
      The study hypothesis is that the use of intravenous magnesium will decrease postoperative&#xD;
      pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and&#xD;
      improve functional recovery in patients undergoing tonsillectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>90 minutes</time_frame>
    <description>Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated &quot;Area Under the Curve&quot; value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain Medication</measure>
    <time_frame>90 minutes</time_frame>
    <description>Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain at Home</measure>
    <time_frame>7 days</time_frame>
    <description>Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergence Delirium</measure>
    <time_frame>5 minutes after awakening in the recovery room</time_frame>
    <description>The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Postoperative Vomiting</measure>
    <time_frame>90 minutes</time_frame>
    <description>The incidence of postoperative vomiting will be measured while in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Depression</measure>
    <time_frame>90 minutes</time_frame>
    <description>The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PACU Discharge</measure>
    <time_frame>Approximately 90 minutes</time_frame>
    <description>The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Satisfaction</measure>
    <time_frame>7 days</time_frame>
    <description>Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium</intervention_name>
    <arm_group_label>Magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>Placebo infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under&#xD;
             the care of that participating surgeon&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) patient classification of I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or developmental delay&#xD;
&#xD;
          -  Psychiatric illness&#xD;
&#xD;
          -  Current use of sedative or anticonvulsant medication&#xD;
&#xD;
          -  Pre-existing renal disease&#xD;
&#xD;
          -  Pre-existing cardiovascular disease&#xD;
&#xD;
          -  Regular use of analgesic medication&#xD;
&#xD;
          -  Having other procedures in addition to tonsillectomy (however, patients undergoing&#xD;
             adenoidectomy with their tonsillectomy will be included in the study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert A Benzon, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>May 7, 2018</results_first_submitted>
  <results_first_submitted_qc>November 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2018</results_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</investigator_affiliation>
    <investigator_full_name>Hubert Benzon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Magnesium</title>
          <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
        </group>
        <group group_id="P2">
          <title>Placebo Infusion</title>
          <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Magnesium</title>
          <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
        </group>
        <group group_id="B2">
          <title>Placebo Infusion</title>
          <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.5" lower_limit="65" upper_limit="94"/>
                    <measurement group_id="B2" value="76.5" lower_limit="61" upper_limit="92"/>
                    <measurement group_id="B3" value="76.5" lower_limit="63" upper_limit="92"/>
                  </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="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.1" lower_limit="14.3" upper_limit="18.2"/>
                    <measurement group_id="B2" value="16.9" lower_limit="14.4" upper_limit="20.0"/>
                    <measurement group_id="B3" value="16.4" lower_limit="14.2" upper_limit="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Obstructive Sleep Apnea (Yes/No)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgical Duration</title>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.5" lower_limit="32" upper_limit="40"/>
                    <measurement group_id="B2" value="35" lower_limit="33" upper_limit="39"/>
                    <measurement group_id="B3" value="35" lower_limit="33" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain</title>
        <description>Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated &quot;Area Under the Curve&quot; value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.</description>
        <time_frame>90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain</title>
          <description>Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated &quot;Area Under the Curve&quot; value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.</description>
          <units>scores on a scale*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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="0" upper_limit="120"/>
                    <measurement group_id="O2" value="45" lower_limit="0" upper_limit="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Pain Medication</title>
        <description>Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.</description>
        <time_frame>90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Medication</title>
          <description>Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.</description>
          <units>mg IV morphine</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0.0" upper_limit="4.44"/>
                    <measurement group_id="O2" value="2.5" lower_limit="0" upper_limit="4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Pain at Home</title>
        <description>Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain at Home</title>
          <description>Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.</description>
          <units>PPPM Scale Score (Range: 0-15)</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4" upper_limit="7"/>
                    <measurement group_id="O2" value="5" lower_limit="2" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Emergence Delirium</title>
        <description>The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.</description>
        <time_frame>5 minutes after awakening in the recovery room</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Emergence Delirium</title>
          <description>The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.</description>
          <units>Units on a scale, PAED</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="11"/>
                    <measurement group_id="O2" value="6.5" lower_limit="0" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Postoperative Vomiting</title>
        <description>The incidence of postoperative vomiting will be measured while in the recovery room.</description>
        <time_frame>90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Postoperative Vomiting</title>
          <description>The incidence of postoperative vomiting will be measured while in the recovery room.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Depression</title>
        <description>The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.</description>
        <time_frame>90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Depression</title>
          <description>The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to PACU Discharge</title>
        <description>The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded</description>
        <time_frame>Approximately 90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Time to PACU Discharge</title>
          <description>The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" spread="19"/>
                    <measurement group_id="O2" value="62" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent Satisfaction</title>
        <description>Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magnesium</title>
            <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
          </group>
          <group group_id="O2">
            <title>Placebo Infusion</title>
            <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Satisfaction</title>
          <description>Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.</description>
          <units>Units on a Numeric Rating 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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="10" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="10" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Magnesium</title>
          <description>Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.&#xD;
Magnesium</description>
        </group>
        <group group_id="E2">
          <title>Placebo Infusion</title>
          <description>Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.&#xD;
Normal saline</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>
    <point_of_contact>
      <name_or_title>Hubert Benzon, MD; Primary Investigator</name_or_title>
      <organization>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</organization>
      <phone>312-227-5122</phone>
      <email>hbenzon@luriechildrens.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/NCT02218424
org study id: 2014MagRCT
nct id: NCT02218424
lead sponsor: 
has dmc: Yes
This study is a double-blind randomized controlled trial using intravenous magnesium versus
      placebo to determine if systemic magnesium can decrease postoperative pain in pediatric
      patients undergoing tonsillectomy.

      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg
      bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of
      normal saline bolus followed by infusion (placebo).

      The primary objective is to determine if systemic magnesium will decrease postoperative pain
      in patients undergoing tonsillectomy. The secondary objectives will determine if systemic
      magnesium administration is associated with a decrease in opioid-related side effects,
      decrease the incidence of emergence delirium, and improve postoperative functional recovery.

      The study hypothesis is that the use of intravenous magnesium will decrease postoperative
      pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and
      improve functional recovery in patients undergoing tonsillectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative Pain
time frame: 90 minutes
description: Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated "Area Under the Curve" value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.
measure: Postoperative Pain Medication
time frame: 90 minutes
description: Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.
measure: Postoperative Pain at Home
time frame: 7 days
description: Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.
measure: Emergence Delirium
time frame: 5 minutes after awakening in the recovery room
description: The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.
measure: Number of Patients With Postoperative Vomiting
time frame: 90 minutes
description: The incidence of postoperative vomiting will be measured while in the recovery room.
measure: Respiratory Depression
time frame: 90 minutes
description: The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.
measure: Time to PACU Discharge
time frame: Approximately 90 minutes
description: The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded
measure: Parent Satisfaction
time frame: 7 days
description: Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.
arm group label: Magnesium
arm group type: Experimental
description: Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.
arm group label: Placebo infusion
arm group type: Placebo Comparator
description: Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.
intervention type: Drug
intervention name: Magnesium
arm group label: Magnesium
intervention type: Drug
intervention name: Normal saline
arm group label: Placebo infusion
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hubert A Benzon, MD, MPH
role: Principal Investigator
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
investigator full name: Hubert Benzon
investigator title: Principal Investigator
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 