<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/NCT01707420</url>
  </required_header>
  <id_info>
    <org_study_id>11-1687</org_study_id>
    <nct_id>NCT01707420</nct_id>
  </id_info>
  <brief_title>Preoperative Gabapentin for Post-tonsillectomy Pain in Children</brief_title>
  <official_title>Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The typical post-operative course for children following surgical removal of their tonsils&#xD;
      and adenoids can be challenging, especially for pain control. First line medications for pain&#xD;
      include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory&#xD;
      drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be&#xD;
      short-lived. Gabapentin has been shown in adult studies to tone down the body's response to&#xD;
      pain and decreases opioid use post-operatively. The purpose of this study is to see if a&#xD;
      single preoperative dose will reduce post-operative pain scores and the amount of analgesic&#xD;
      used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blind, placebo-controlled trial to study the effect of a&#xD;
      preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective&#xD;
      pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also&#xD;
      look for a limited set of genotypic variations to explain any difference between individuals&#xD;
      or groups in their response to the medication. Additionally, investigators will document&#xD;
      potential adverse effects including excessive sedation, respiratory issues, surgical bleeding&#xD;
      and emergence agitation/delirium.&#xD;
&#xD;
      Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain&#xD;
      scores up to 36 hours post adenotonsillectomy without increased adverse effects such as&#xD;
      emergence delirium, respiratory complications or bleeding. The clinical effect may depend on&#xD;
      the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms&#xD;
      that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic&#xD;
      pain medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</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>Total Oral Analgesia Consumption</measure>
    <time_frame>Up to 36 hours</time_frame>
    <description>Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-report Pain Score at Rest</measure>
    <time_frame>Up to 36 hours</time_frame>
    <description>Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report Pain Score When Swallowing</measure>
    <time_frame>Up to 36 hours</time_frame>
    <description>Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gabapentin, 20 mg/kg, single dose, 60 min prior to surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>liquid placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Neurontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liquid placebo</intervention_name>
    <description>Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.</description>
    <arm_group_label>liquid placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for outpatient tonsillectomy and adenoidectomy&#xD;
&#xD;
          -  &lt; 60 Kg, between 5th and 95th percentile for weight&#xD;
&#xD;
          -  ability to self-report pain&#xD;
&#xD;
          -  complete pain diary with assistance from parent or guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  require pre-anesthesia medication for anxiety&#xD;
&#xD;
          -  require interpreter for verbal or written communication&#xD;
&#xD;
          -  Obstructive sleep apnea significant enough to not qualify for outpatient surgery per&#xD;
             surgeon&#xD;
&#xD;
          -  ongoing oxygen dependence, pulmonary hypertension&#xD;
&#xD;
          -  elevated risk of regurgitation&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  currently taking psychoactive medications or having a psychiatric condition requiring&#xD;
             medications&#xD;
&#xD;
          -  chronic pain disorders requiring medications&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  developmental or cognitive disabilities&#xD;
&#xD;
          -  history of adverse reactions to components of liquid gabapentin or placebo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Notides, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>November 4, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 15, 2021</results_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric pain</keyword>
  <keyword>post operative pain</keyword>
  <keyword>opioids</keyword>
  <keyword>emergence agitation</keyword>
  <keyword>preoperative anxiety</keyword>
  <keyword>pharmacogenomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Group</title>
          <description>Participants received placebo prior to tonsillectomy</description>
        </group>
        <group group_id="P2">
          <title>Gabapentin Group</title>
          <description>Participants received gabapentin prior to tonsillectomy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </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>Placebo</title>
          <description>Placebo group</description>
        </group>
        <group group_id="B2">
          <title>Gabapentin</title>
          <description>Gabapentin</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="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Median age (years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" lower_limit="5" upper_limit="14"/>
                    <measurement group_id="B2" value="8.0" lower_limit="5" upper_limit="15"/>
                    <measurement group_id="B3" value="8.0" lower_limit="5" upper_limit="15"/>
                  </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="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Oral Analgesia Consumption</title>
        <description>Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.</description>
        <time_frame>Up to 36 hours</time_frame>
        <population>Healthy children aged 5 - 16 years old.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Participants received placebo prior to tonsillectomy</description>
          </group>
          <group group_id="O2">
            <title>Gabapentin Group</title>
            <description>Participants received gabapentin prior to tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Total Oral Analgesia Consumption</title>
          <description>Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.</description>
          <population>Healthy children aged 5 - 16 years old.</population>
          <units>cumulative hydrocodone (mg/kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 36h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.228" spread="0.106"/>
                    <measurement group_id="O2" value="0.224" spread="0.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 24h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.200" spread="0.107"/>
                    <measurement group_id="O2" value="0.193" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 12h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.171" spread="0.079"/>
                    <measurement group_id="O2" value="0.165" spread="0.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 8h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.157" spread="0.067"/>
                    <measurement group_id="O2" value="0.132" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 4h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.135" spread="0.060"/>
                    <measurement group_id="O2" value="0.109" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 1.5h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.127" spread="0.060"/>
                    <measurement group_id="O2" value="0.087" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.121" spread="0.067"/>
                    <measurement group_id="O2" value="0.087" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 0.5h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.107" spread="0.077"/>
                    <measurement group_id="O2" value="0.068" spread="0.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cumulative hydrocodone (mg/kg) at 0h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.079" spread="0.077"/>
                    <measurement group_id="O2" value="0.011" spread="0.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-report Pain Score at Rest</title>
        <description>Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.</description>
        <time_frame>Up to 36 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin Group</title>
            <description>The gabapentin (treatment) group was given gabapentin, at a single dose of 20 mg/kg, 60 min prior to surgery in liquid form of less than 0.4 mL/kg total volume.&#xD;
This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid gabapentin given 60 minutes prior to surgery for post-op pain management in healthy pediatric tonsillectomy/adenoidectomy patients.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Participants randomized to the placebo arm will received a single dose of placebo, an identical appearing mixture of sweetener, thickener, and water of equal volume, also given 60 min prior to surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-report Pain Score at Rest</title>
          <description>Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.</description>
          <units>score 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="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0.5 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.33" spread="2.94"/>
                    <measurement group_id="O2" value="5.08" spread="2.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.0 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="2.74"/>
                    <measurement group_id="O2" value="5.80" spread="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="2.45"/>
                    <measurement group_id="O2" value="3.60" spread="3.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="2.70"/>
                    <measurement group_id="O2" value="3.00" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="2.57"/>
                    <measurement group_id="O2" value="2.71" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread="2.34"/>
                    <measurement group_id="O2" value="4.20" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" spread="2.32"/>
                    <measurement group_id="O2" value="4.61" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="1.74"/>
                    <measurement group_id="O2" value="4.00" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-report Pain Score When Swallowing</title>
        <description>Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.</description>
        <time_frame>Up to 36 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin Group</title>
            <description>The gabapentin (treatment) group was given gabapentin, at a single dose of 20 mg/kg, 60 min prior to surgery in liquid form of less than 0.4 mL/kg total volume.&#xD;
This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid gabapentin given 60 minutes prior to surgery for post-op pain management in healthy pediatric tonsillectomy/adenoidectomy patients.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Participants randomized to the placebo arm will received a single dose of placebo, an identical appearing mixture of sweetener, thickener, and water of equal volume, also given 60 min prior to surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-report Pain Score When Swallowing</title>
          <description>Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.</description>
          <units>score 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="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0.5 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.47" spread="3.16"/>
                    <measurement group_id="O2" value="5.42" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.78" spread="2.95"/>
                    <measurement group_id="O2" value="6.00" spread="3.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.40" spread="3.71"/>
                    <measurement group_id="O2" value="5.50" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.30" spread="1.64"/>
                    <measurement group_id="O2" value="4.27" spread="3.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.30" spread="2.67"/>
                    <measurement group_id="O2" value="4.00" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.86" spread="2.27"/>
                    <measurement group_id="O2" value="4.80" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.46" spread="2.88"/>
                    <measurement group_id="O2" value="5.65" spread="3.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" spread="2.41"/>
                    <measurement group_id="O2" value="5.13" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo group</description>
        </group>
        <group group_id="E2">
          <title>Gabapentin</title>
          <description>Gabapentin group</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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Unplanned admission post tonsillectomy</sub_title>
                <description>Participants were scheduled for outpatient, same-day surgery. We tracked the number of patients from each group that needed to be admitted, unplanned, to the inpatient hospital unit post-op for any reason.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="18"/>
              </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>Thomas Notides</name_or_title>
      <organization>University of Colorado</organization>
      <phone>720-777-6005</phone>
      <email>thomas.notides@childrenscolorado.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/NCT01707420
org study id: 11-1687
nct id: NCT01707420
lead sponsor: 
has dmc: No
The typical post-operative course for children following surgical removal of their tonsils
      and adenoids can be challenging, especially for pain control. First line medications for pain
      include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory
      drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be
      short-lived. Gabapentin has been shown in adult studies to tone down the body's response to
      pain and decreases opioid use post-operatively. The purpose of this study is to see if a
      single preoperative dose will reduce post-operative pain scores and the amount of analgesic
      used.
This is a randomized, double blind, placebo-controlled trial to study the effect of a
      preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective
      pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also
      look for a limited set of genotypic variations to explain any difference between individuals
      or groups in their response to the medication. Additionally, investigators will document
      potential adverse effects including excessive sedation, respiratory issues, surgical bleeding
      and emergence agitation/delirium.

      Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain
      scores up to 36 hours post adenotonsillectomy without increased adverse effects such as
      emergence delirium, respiratory complications or bleeding. The clinical effect may depend on
      the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms
      that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic
      pain medications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Total Oral Analgesia Consumption
time frame: Up to 36 hours
description: Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
measure: Self-report Pain Score at Rest
time frame: Up to 36 hours
description: Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.
measure: Self-report Pain Score When Swallowing
time frame: Up to 36 hours
description: Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.
arm group label: Gabapentin
arm group type: Active Comparator
description: gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
arm group label: liquid placebo
arm group type: Placebo Comparator
description: subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery
intervention type: Drug
intervention name: Gabapentin
description: The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.
arm group label: Gabapentin
other name: Neurontin
intervention type: Drug
intervention name: liquid placebo
description: Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
arm group label: liquid placebo
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Thomas Notides, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Gabapentin
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 