<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/NCT04423107</url>
  </required_header>
  <id_info>
    <org_study_id>Hypospadias Repair Project</org_study_id>
    <nct_id>NCT04423107</nct_id>
  </id_info>
  <brief_title>Assessment of Postop Hypospadias Pain</brief_title>
  <official_title>Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the most common pediatric urology procedures is hypospadias repair, a surgery to&#xD;
      correct curvature of the penis and move the urethral meatus into the glans. A survey of&#xD;
      pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain&#xD;
      medication following the procedure. Using a validated questionnaire, the investigators aim to&#xD;
      quantify how much opioid pain medication boys undergoing hypospadias repair require and if&#xD;
      opioid pain medication can be eliminated from the routine postoperative medication regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will&#xD;
      not be statistically different in boys who receive opioid pain medication postoperatively&#xD;
      compared to boys who do not.&#xD;
&#xD;
      The long-term objectives of this study are to understand if pre and postoperative counseling&#xD;
      and education along with proper surgical technique will result in less opioid prescriptions&#xD;
      following hypospadias repair.&#xD;
&#xD;
      Children with suspected hypospadias will be seen and examined in clinic and offered surgery&#xD;
      if appropriate. If the families elect for surgery, this will be performed by one of the&#xD;
      investigators between 6-12 months of age. The surgical technique may vary among the&#xD;
      investigators. Patients with severe hypospadias may require multiple surgeries for&#xD;
      correction.&#xD;
&#xD;
      On the day of surgery, patients will be randomized to receive one of two pain medication&#xD;
      regimens:&#xD;
&#xD;
        1. Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h&#xD;
&#xD;
        2. Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for&#xD;
           10 doses Home dosing regimens will be started six hours after the last hospital dose of&#xD;
           each medication. The families will be instructed as to when they can give oral&#xD;
           medications at home. Lastly, families of both children in both groups will be instructed&#xD;
           to contact the clinic or urologist on call if their children are experiencing&#xD;
           uncontrolled pain. This may necessitate evaluation in person or adjustment of the&#xD;
           current pain regimen. Any deviation from to prescribed pain regimen will be recorded for&#xD;
           the study.&#xD;
&#xD;
      Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated&#xD;
      questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how&#xD;
      much discomfort boys in both groups experienced.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Hypospadias</condition>
  <arm_group>
    <arm_group_label>No opioid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acetaminophen every 6 hours and Ibuprofen every 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen, Ibuprofen</intervention_name>
    <description>Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h</description>
    <arm_group_label>No opioid</arm_group_label>
    <other_name>Tylenol (Acetaminophen)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen, Ibuprofen, Oxycodone</intervention_name>
    <description>Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h</description>
    <arm_group_label>Opioid</arm_group_label>
    <other_name>Tylenol (Acetaminophen)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All boys undergoing hypospadias repair at our institution between June 2020 and June 2021&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or&#xD;
        Oxycodone use. Boys over 2 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All boys undergoing hypospadias repair at our institution</gender_description>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>23 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bhalaajee Meenakshi-Sundaram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma HSC, Dept. of Urology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bhalaajee Meenakshi-Sundaram, MD</last_name>
    <phone>405-271-6900</phone>
    <email>Bhalaajee-meenakshi-sundaram@ouhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Felicia Kiplinger, BA</last_name>
    <phone>405-271-6900</phone>
    <email>felicia-kiplinger@ouhsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>OU Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bhalaajee Meenakshi-Sundaram, MD</last_name>
      <phone>405-271-6900</phone>
      <email>bhalaajee-meenakshi-sundaram@ouhsc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric hypospadias repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04423107
org study id: Hypospadias Repair Project
nct id: NCT04423107
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
One of the most common pediatric urology procedures is hypospadias repair, a surgery to
      correct curvature of the penis and move the urethral meatus into the glans. A survey of
      pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain
      medication following the procedure. Using a validated questionnaire, the investigators aim to
      quantify how much opioid pain medication boys undergoing hypospadias repair require and if
      opioid pain medication can be eliminated from the routine postoperative medication regimen.
Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will
      not be statistically different in boys who receive opioid pain medication postoperatively
      compared to boys who do not.

      The long-term objectives of this study are to understand if pre and postoperative counseling
      and education along with proper surgical technique will result in less opioid prescriptions
      following hypospadias repair.

      Children with suspected hypospadias will be seen and examined in clinic and offered surgery
      if appropriate. If the families elect for surgery, this will be performed by one of the
      investigators between 6-12 months of age. The surgical technique may vary among the
      investigators. Patients with severe hypospadias may require multiple surgeries for
      correction.

      On the day of surgery, patients will be randomized to receive one of two pain medication
      regimens:

        1. Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h

        2. Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for
           10 doses Home dosing regimens will be started six hours after the last hospital dose of
           each medication. The families will be instructed as to when they can give oral
           medications at home. Lastly, families of both children in both groups will be instructed
           to contact the clinic or urologist on call if their children are experiencing
           uncontrolled pain. This may necessitate evaluation in person or adjustment of the
           current pain regimen. Any deviation from to prescribed pain regimen will be recorded for
           the study.

      Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated
      questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how
      much discomfort boys in both groups experienced.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale
time frame: 1 year
description: Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale
arm group label: No opioid
arm group type: Active Comparator
description: Acetaminophen every 6 hours and Ibuprofen every 6 hours
arm group label: Opioid
arm group type: Active Comparator
description: Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.
intervention type: Drug
intervention name: Acetaminophen, Ibuprofen
description: Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
arm group label: No opioid
other name: Tylenol (Acetaminophen)
intervention type: Drug
intervention name: Acetaminophen, Ibuprofen, Oxycodone
description: Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
arm group label: Opioid
other name: Tylenol (Acetaminophen)
criteria: 
gender: Male
gender based: Yes
gender description: All boys undergoing hypospadias repair at our institution
minimum age: 6 Months
maximum age: 23 Months
healthy volunteers: No
last name: Bhalaajee Meenakshi-Sundaram, MD
role: Principal Investigator
affiliation: University of Oklahoma HSC, Dept. of Urology
last name: Bhalaajee Meenakshi-Sundaram, MD
phone: 405-271-6900
email: Bhalaajee-meenakshi-sundaram@ouhsc.edu
last name: Felicia Kiplinger, BA
phone: 405-271-6900
email: felicia-kiplinger@ouhsc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hypospadias
mesh term: Acetaminophen
mesh term: Ibuprofen
mesh term: Oxycodone
sharing ipd: No