<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/NCT03001843</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201500836 -A</org_study_id>
    <nct_id>NCT03001843</nct_id>
  </id_info>
  <brief_title>Ketamine vs Hydromorphone</brief_title>
  <official_title>Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help to determine if investigators can minimize narcotic use in laparoscopic&#xD;
      gastric bypass patients while maintaining adequate pain control. This will allow&#xD;
      investigators to minimize the negative side effects of narcotics which is a goal in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a head to head observational study of patients who have undergone gastric&#xD;
      bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic.&#xD;
      Both are FDA approved methods of delivering anesthesia.&#xD;
&#xD;
      The amount of narcotics a patient receives is part of the medical record post-operatively&#xD;
      will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of&#xD;
      narcotics needed to control the patient's pain (converted to morphine equivalent units) and&#xD;
      pain scores (a hospital standard measure) will be collected for 48 hours for the study, or&#xD;
      until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows&#xD;
      investigators to compare different narcotics the patient may receive in a more standardized&#xD;
      way. The results will be analyzed and compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Measured Based on Pain Medication Used on a Scale of 0-10</measure>
    <time_frame>48 hours</time_frame>
    <description>Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (Hours)</measure>
    <time_frame>48 hours</time_frame>
    <description>Length of stay compared between the 2 groups in hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Laparoscopic Gastric Bypass</condition>
  <condition>Obesity</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Non-Ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Anesthesia of only Ketamine</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>Ketalar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Narcotics</intervention_name>
    <description>The narcotic group will receive no ketamine but rather a more standard anesthetic</description>
    <arm_group_label>Non-Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>pain scale</intervention_name>
    <description>0-10 pain scale. 0 = no pain and 10 = worst pain</description>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_label>Non-Ketamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of&#xD;
             age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M Smyth, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shands Hospital at the University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>May 27, 2020</results_first_submitted>
  <results_first_submitted_qc>February 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2021</results_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Ketamine</mesh_term>
    <mesh_term>Narcotics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03001843/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03001843/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-Ketamine</title>
          <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.&#xD;
Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
        </group>
        <group group_id="P2">
          <title>Ketamine</title>
          <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.&#xD;
Ketamine: Anesthesia of only Ketamine&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </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>Non-Ketamine</title>
          <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.&#xD;
Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
        </group>
        <group group_id="B2">
          <title>Ketamine</title>
          <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.&#xD;
Ketamine: Anesthesia of only Ketamine&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</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="27"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Data not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="44"/>
                  </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>
          <population>Data not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Measured Based on Pain Medication Used on a Scale of 0-10</title>
        <description>Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Ketamine</title>
            <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.&#xD;
Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
          </group>
          <group group_id="O2">
            <title>Ketamine</title>
            <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.&#xD;
Ketamine: Anesthesia of only Ketamine&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Measured Based on Pain Medication Used on a Scale of 0-10</title>
          <description>Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="2.2"/>
                    <measurement group_id="O2" value="0.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay (Hours)</title>
        <description>Length of stay compared between the 2 groups in hours.</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Ketamine</title>
            <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.&#xD;
Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
          </group>
          <group group_id="O2">
            <title>Ketamine</title>
            <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.&#xD;
Ketamine: Anesthesia of only Ketamine&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay (Hours)</title>
          <description>Length of stay compared between the 2 groups in hours.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" spread="20.6"/>
                    <measurement group_id="O2" value="39.8" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-Ketamine</title>
          <description>This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.&#xD;
Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</description>
        </group>
        <group group_id="E2">
          <title>Ketamine</title>
          <description>This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.&#xD;
Ketamine: Anesthesia of only Ketamine&#xD;
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </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>Joshua Sappenfield, MD</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-273-5259</phone>
      <email>jsappenfield@anest.ufl.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03001843
org study id: IRB201500836 -A
nct id: NCT03001843
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will help to determine if investigators can minimize narcotic use in laparoscopic
      gastric bypass patients while maintaining adequate pain control. This will allow
      investigators to minimize the negative side effects of narcotics which is a goal in this
      population.
The study will be a head to head observational study of patients who have undergone gastric
      bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic.
      Both are FDA approved methods of delivering anesthesia.

      The amount of narcotics a patient receives is part of the medical record post-operatively
      will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of
      narcotics needed to control the patient's pain (converted to morphine equivalent units) and
      pain scores (a hospital standard measure) will be collected for 48 hours for the study, or
      until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows
      investigators to compare different narcotics the patient may receive in a more standardized
      way. The results will be analyzed and compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Pain Measured Based on Pain Medication Used on a Scale of 0-10
time frame: 48 hours
description: Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale
measure: Length of Stay (Hours)
time frame: 48 hours
description: Length of stay compared between the 2 groups in hours.
arm group label: Non-Ketamine
arm group type: Active Comparator
description: This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
arm group label: Ketamine
arm group type: Active Comparator
description: This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
intervention type: Drug
intervention name: Ketamine
description: Anesthesia of only Ketamine
arm group label: Ketamine
other name: Ketalar
intervention type: Drug
intervention name: Narcotics
description: The narcotic group will receive no ketamine but rather a more standard anesthetic
arm group label: Non-Ketamine
intervention type: Behavioral
intervention name: pain scale
description: 0-10 pain scale. 0 = no pain and 10 = worst pain
arm group label: Ketamine
arm group label: Non-Ketamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David M Smyth, MSN
role: Principal Investigator
affiliation: Shands Hospital at the University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Ketamine
mesh term: Narcotics
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 