<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/NCT01667120</url>
  </required_header>
  <id_info>
    <org_study_id>10-00554</org_study_id>
    <nct_id>NCT01667120</nct_id>
  </id_info>
  <brief_title>The Use of Ketorolac in Surgical Neonates</brief_title>
  <official_title>The Use of Ketorolac in Surgical Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general purpose of this study is to characterize the safety profile of ketorolac in&#xD;
      infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective&#xD;
      in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg&#xD;
      intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%&#xD;
      normal saline as placebo.&#xD;
&#xD;
      Primary: The primary purpose of this study is to compare bleeding events in neonates who&#xD;
      receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that&#xD;
      ketorolac is safe and effective in infants &gt; 37wks gestation and at least one week of age.&#xD;
&#xD;
      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine&#xD;
      output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,&#xD;
      amount of narcotic administered, blood pressure, and reintubation events on all patients in&#xD;
      this study as secondary study points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients&#xD;
      one week of age to 3 months of age who undergo an abdominal surgical procedure within the&#xD;
      moderate or severe degree of pain category (see attached Table 1: postoperative pain&#xD;
      categories) will be randomized to receive standard pain management regimens plus placebo&#xD;
      (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain&#xD;
      management regimens. The postoperative management will be unchanged and at the discretion of&#xD;
      the attending surgeon, as appropriate for the surgical procedure. The patients will be&#xD;
      followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary&#xD;
      endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>Phase 2</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>Safety from bleeding events.</measure>
    <time_frame>5 days</time_frame>
    <description>Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. We hypothesize that ketorolac is safe and effective in infants &gt; 37wks gestation and at least one week of age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters related to pain.</measure>
    <time_frame>5 days</time_frame>
    <description>We intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Postoperative Pain Control in Surgical Neonates</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketorolac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Ketorolac 0.5mg/kg IV q8h x 72h.</description>
    <arm_group_label>Ketorolac</arm_group_label>
    <other_name>Toradol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>0.9% normal saline 1ml/kg</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>0.9% normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infants gestational age &gt; 37 weeks and greater than or equal to one week of age to 3&#xD;
             months of age&#xD;
&#xD;
          2. Infants who are undergoing a surgical procedure on the abdomen&#xD;
&#xD;
          3. the parent or guardian has given informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gestational age &lt; 37 weeks&#xD;
&#xD;
          2. Age less than one week or greater than 3 months of age&#xD;
&#xD;
          3. Known renal disease/dysplastic kidneys&#xD;
&#xD;
          4. Serum Creatinine &gt; 0.4&#xD;
&#xD;
          5. Patients who have rising creatinine levels the day prior to surgery (increase of at&#xD;
             least 1.5-fold from baseline)&#xD;
&#xD;
          6. Patients who are currently receiving other potentially renal toxic drugs or drugs that&#xD;
             may interfere with hemostatic pathways as part of their clinical care (including but&#xD;
             not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa&#xD;
             [except for use of thrombosed central venous catheters], enalapril, systemic heparin&#xD;
             [except for use in central venous catheter flushes])&#xD;
&#xD;
          7. Patients who undergo nephrectomy&#xD;
&#xD;
          8. Patients with necrotizing enterocolitis&#xD;
&#xD;
          9. Patients with a hemoglobin value &lt; 10g/dL&#xD;
&#xD;
         10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation&#xD;
&#xD;
         11. Platelet count &lt; 50,000&#xD;
&#xD;
         12. Ongoing disseminated intravascular coagulation or history of intraventricular&#xD;
             hemorrhage&#xD;
&#xD;
         13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory&#xD;
             drugs (NSAIDS) besides aspirin (ASA)&#xD;
&#xD;
         14. Allergy to ASA or other NSAIDS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer H Aldrink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</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 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ketorolac</keyword>
  <keyword>postoperative pain</keyword>
  <keyword>bleeding events</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>Ketorolac</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01667120
org study id: 10-00554
nct id: NCT01667120
lead sponsor: 
has dmc: Yes
The general purpose of this study is to characterize the safety profile of ketorolac in
      infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective
      in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg
      intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%
      normal saline as placebo.

      Primary: The primary purpose of this study is to compare bleeding events in neonates who
      receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that
      ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.

      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine
      output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,
      amount of narcotic administered, blood pressure, and reintubation events on all patients in
      this study as secondary study points.
This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients
      one week of age to 3 months of age who undergo an abdominal surgical procedure within the
      moderate or severe degree of pain category (see attached Table 1: postoperative pain
      categories) will be randomized to receive standard pain management regimens plus placebo
      (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain
      management regimens. The postoperative management will be unchanged and at the discretion of
      the attending surgeon, as appropriate for the surgical procedure. The patients will be
      followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary
      endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety from bleeding events.
time frame: 5 days
description: Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. We hypothesize that ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.
measure: Clinical parameters related to pain.
time frame: 5 days
description: We intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.
arm group label: Placebo
arm group type: Placebo Comparator
description: Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.
arm group label: Ketorolac
arm group type: Experimental
description: Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.
intervention type: Drug
intervention name: Ketorolac
description: Ketorolac 0.5mg/kg IV q8h x 72h.
arm group label: Ketorolac
other name: Toradol
intervention type: Drug
intervention name: placebo
description: 0.9% normal saline 1ml/kg
arm group label: Placebo
other name: 0.9% normal saline
criteria: 
gender: All
minimum age: 1 Week
maximum age: 3 Months
healthy volunteers: No
last name: Jennifer H Aldrink, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Ketorolac