<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/NCT03759028</url>
  </required_header>
  <id_info>
    <org_study_id>IRB# 18-001158</org_study_id>
    <nct_id>NCT03759028</nct_id>
  </id_info>
  <brief_title>Supracondylar Post-Operative Pain Study</brief_title>
  <official_title>A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to investigate post-operative pain control in pediatric patients&#xD;
      with closed supracondylar humerus fracture who undergo closed reduction and percutaneous&#xD;
      pinning. Currently, it is standard of care that patients receive a narcotic prescription for&#xD;
      post-operative pain control. All patients will initially be seen in our pediatric urgent care&#xD;
      and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen&#xD;
      and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the&#xD;
      acetaminophen but both investigators, parents and the patients will be blinded to the study&#xD;
      drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale&#xD;
      and parents will be asked to fill out a questionnaire regarding their satisfaction with the&#xD;
      surgery and pain control. Parents will also fill out a medication log until the patient no&#xD;
      longer requires pain medication. The duration of participation in the study is approximately&#xD;
      1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This&#xD;
      study is being conducted in hopes of reducing opioid prescription after surgical fixation of&#xD;
      uncomplicated supracondylar humerus fractures if our study can show that patient's pain&#xD;
      levels post-operatively and parent/patient satisfaction are unchanged or improved in the&#xD;
      acetaminophen and ibuprofen arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blinded, randomized controlled trial comparing the analgesic efficacy&#xD;
      between acetaminophen and ibuprofen versus acetaminophen and oxycodone for postoperative pain&#xD;
      control in patients following closed reduction and percutaneous pinning for isolated closed&#xD;
      supracondylar humerus fractures. Each patient will be evaluated initially at our&#xD;
      institution's pediatric urgent care center and placed in a long arm splint with instructions&#xD;
      to elevate the affected arm. Patients will not be discharged with any prescriptions for&#xD;
      narcotic pain medication and will be instructed to take weight-based doses of acetaminophen&#xD;
      and/or ibuprofen for pain control as needed.&#xD;
&#xD;
      All patients age 5-12 with closed Gartland type II supracondylar humerus fractures requiring&#xD;
      fixation (e.g. satisfactory reduction not achieved with closed reduction and casting or&#xD;
      medial column comminution) and Gartland type III supracondylar humerus fractures scheduled&#xD;
      for surgery will be approached for participation in the study. Demographic data (age, gender,&#xD;
      weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained&#xD;
      through chart review on each included patient.&#xD;
&#xD;
      The exclusion criteria include open fractures, fractures with concomitant vascular or&#xD;
      neurologic deficit, any fracture requiring open reduction, pathologic fractures, those&#xD;
      presenting with concomitant injuries, swelling requiring post-operative hospitalization for&#xD;
      monitoring, any known history of allergies to acetaminophen, ibuprofen or oxycodone, and&#xD;
      patients with developmental delay that would preclude participation in the visual analog&#xD;
      Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to&#xD;
      participate in the study, and assent will be obtained from patients when possible. If parents&#xD;
      refuse participation in the study, the reason for refusal will be documented, and their&#xD;
      child's care and post-operative protocol will be consistent with our typical protocol, which&#xD;
      includes all 3 medications.&#xD;
&#xD;
      All surgeries will be performed at our outpatient surgery center. The treating pediatric&#xD;
      anesthesiologists will use a standardized anesthesia protocol. All patients will be under&#xD;
      general anesthesia and will not receive any regional anesthetics or local anesthetics. All&#xD;
      included patients will undergo closed reduction and percutaneous pinning using 2-3 pins&#xD;
      placed either all laterally or medially and laterally by two pediatric orthopaedic surgeons&#xD;
      (MS and RT). They will al be placed in posterior long arm splints thereafter and made&#xD;
      non-weight bearing in that extremity. The patients will be transferred to our post-anesthesia&#xD;
      care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed for before discharge&#xD;
      home. Nursing staff will record the amount of pain medication provided in the PACU as well as&#xD;
      the pre-discharge pain scores, as is our typical post-operative protocol.&#xD;
&#xD;
      Prior to discharge, patients will be randomized to receiving acetaminophen for first-line&#xD;
      medication (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day)&#xD;
      with as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8&#xD;
      hours as needed, max dose 40mg/kg/day) or acetaminophen for first-line medication (liquid&#xD;
      oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) with as needed&#xD;
      oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as&#xD;
      needed). Each patient will receive 18 doses (3 days) of acetaminophen and the study&#xD;
      medication. Pre-sealed, sequentially numbered randomization envelopes containing each&#xD;
      subject's group will be delivered to the hospital pharmacy. Patients will be instructed to&#xD;
      first take the labeled acetaminophen medication and to take the study medication (unlabeled)&#xD;
      as needed for breakthrough pain as prescribed. Patients will be given both patient&#xD;
      information for both study medications in order to keep the patients blinded to which study&#xD;
      medication they received. They will be given patient information for both medications but&#xD;
      told that they have been given only one of the two medications. Medication labels will be&#xD;
      obscured by the pharmacist with a circumferential tape. Throughout the study, the&#xD;
      investigators and the parents will be blinded as to which study medication was given to each&#xD;
      participant. Parents who contact the physician (a resident physician on-call for the&#xD;
      pediatric orthopaedic surgery service who is not involved in the study) post-operatively for&#xD;
      alternative pain medication will be provided the study medication not initially provided&#xD;
      (i.e. those that were randomized to receive oxycodone primarily will be provided ibuprofen&#xD;
      and vice versa), as confirmed by our pharmacy.&#xD;
&#xD;
      Post-operatively, the parents of each participant will be asked to use the Faces Pain&#xD;
      Scale-Revised (FPS-R)16 to rate the child's level of pain at 24 hours and 48 hours after&#xD;
      surgery. A research team member will call each participant's guardian at 24 and 48 hours&#xD;
      post-operatively to collect these responses. Parents will further be asked to complete the&#xD;
      modified Total Quality Pain Management Instrument (TQPM)17 regarding their level of&#xD;
      satisfaction with surgery and post-operative pain control. Parents will be asked to report&#xD;
      any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the&#xD;
      medications. A take-home medication log will be utilized by the parents to record the type&#xD;
      and amount of mediation given to each participant and to record any associated side effects.&#xD;
&#xD;
      For breakthrough pain experienced during pharmacy hours the patient will have the option to&#xD;
      return to our pharmacy to obtain the medication they were not originally prescribed. Though&#xD;
      the investigators believe this will be unlikely, if they are unable to get to the pharmacy&#xD;
      for the other medication (e.g. oxycodone if they were in the ibuprofen group or ibuprofen if&#xD;
      they were in the oxycodone group), parents can go to the ER for IM/IV medication for pain&#xD;
      relief and they can get a prescription for oxycodone or ibuprofen from the ER if necessary,&#xD;
      once they contact the resident on call. There will always be a resident on call 24/7 to&#xD;
      advise patients if they are unable to achieve adequate pain control with medications&#xD;
      received. Again, the study group believes this will be an unlikely/rare event. The resident&#xD;
      on call will have access to the study medication that the patient received. At this point,&#xD;
      the resident on call can reveal what medication they were getting (in case they need a new&#xD;
      prescription from the ER) so they do not get oxycodone if they were already prescribed&#xD;
      oxycodone (and can get something different) or they have the option to obtain ibuprofen&#xD;
      over-the-counter if they wish. Patients who need to get the other medication would be&#xD;
      considered a &quot;failure in treatment&quot; and would not be analyzed together from the original&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</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>
    <intervention_model_description>double blinded, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Randomization envelopes used to allocate treatment groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Faces Pain Scale-Revised (FPSR)</measure>
    <time_frame>24 to 48 hours post-operatively</time_frame>
    <description>Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Quality Pain Management Instrument</measure>
    <time_frame>1 week at first post-operative follow-up</time_frame>
    <description>Questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions re: post-operative pain management including domains in pain experience, pain relief, adverse effects, future analgesic use. The majority of the questions are binary, but there are a few questions that include a mild, moderate, severe option. There is no numerical output, and the subscales are not combined.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain medication logs</measure>
    <time_frame>Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.</time_frame>
    <description>Self report take home medication logs recording the time, type, dosage, and side effects of medication</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Supracondylar Humerus Fracture</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as needed).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.</description>
    <arm_group_label>Ibuprofen</arm_group_label>
    <other_name>Advil, Motrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.</description>
    <arm_group_label>Oxycodone</arm_group_label>
    <other_name>roxicodone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.</description>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_label>Oxycodone</arm_group_label>
    <other_name>Tylenol, Paracetamol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Closed supracondylar humerus fracture&#xD;
&#xD;
          -  Isolated supracondylar humerus fracture&#xD;
&#xD;
          -  Type II and III supracondylar humerus fracture&#xD;
&#xD;
          -  Fracutres treated with closed reduction percutaneous pinning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractures with concomitant vascular injury&#xD;
&#xD;
          -  Fractures with concomitant neurologic deficit&#xD;
&#xD;
          -  Pathologic fractures&#xD;
&#xD;
          -  Fractures with concomitant injuries (multiple trauma)&#xD;
&#xD;
          -  Fractures with swelling requiring post-operative hospitalization for monitoring&#xD;
&#xD;
          -  Known history of allergies to acetaminophen, ibuprofen or oxycodone&#xD;
&#xD;
          -  Patients with developmental delay that would preclude participation in the visual&#xD;
             analog Faces Pain Scale-Revised&#xD;
&#xD;
          -  Patients with intellectual disability that would preclude participation in the visual&#xD;
             analog Faces Pain Scale-Revised&#xD;
&#xD;
          -  History of suspected child abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel M Thompson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA/OIC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jared M Alswang</last_name>
    <phone>2137426537</phone>
    <email>jalswang@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christina K Sun, MS</last_name>
    <phone>2137421057</phone>
    <email>CKSun@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Orthopaedic Institute for Children</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jared Alswang</last_name>
      <phone>213-742-6537</phone>
      <email>JAlswang@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Christina K Sun</last_name>
      <phone>2137421057</phone>
      <email>CKSun@mednet.ucla.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Rachel Thompson, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>closed reduction percutaneous pinning</keyword>
  <keyword>post-operative pain control</keyword>
  <keyword>opiod</keyword>
  <keyword>pediatric</keyword>
  <keyword>elbow fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Humeral Fractures</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>
  <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>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03759028/Prot_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Parent Consent SCHF Pain</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>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03759028/ICF_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Child Assent SCHF Pain</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>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03759028/ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03759028
org study id: IRB# 18-001158
nct id: NCT03759028
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study to investigate post-operative pain control in pediatric patients
      with closed supracondylar humerus fracture who undergo closed reduction and percutaneous
      pinning. Currently, it is standard of care that patients receive a narcotic prescription for
      post-operative pain control. All patients will initially be seen in our pediatric urgent care
      and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen
      and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the
      acetaminophen but both investigators, parents and the patients will be blinded to the study
      drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale
      and parents will be asked to fill out a questionnaire regarding their satisfaction with the
      surgery and pain control. Parents will also fill out a medication log until the patient no
      longer requires pain medication. The duration of participation in the study is approximately
      1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This
      study is being conducted in hopes of reducing opioid prescription after surgical fixation of
      uncomplicated supracondylar humerus fractures if our study can show that patient's pain
      levels post-operatively and parent/patient satisfaction are unchanged or improved in the
      acetaminophen and ibuprofen arm.
This is a double-blinded, randomized controlled trial comparing the analgesic efficacy
      between acetaminophen and ibuprofen versus acetaminophen and oxycodone for postoperative pain
      control in patients following closed reduction and percutaneous pinning for isolated closed
      supracondylar humerus fractures. Each patient will be evaluated initially at our
      institution's pediatric urgent care center and placed in a long arm splint with instructions
      to elevate the affected arm. Patients will not be discharged with any prescriptions for
      narcotic pain medication and will be instructed to take weight-based doses of acetaminophen
      and/or ibuprofen for pain control as needed.

      All patients age 5-12 with closed Gartland type II supracondylar humerus fractures requiring
      fixation (e.g. satisfactory reduction not achieved with closed reduction and casting or
      medial column comminution) and Gartland type III supracondylar humerus fractures scheduled
      for surgery will be approached for participation in the study. Demographic data (age, gender,
      weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained
      through chart review on each included patient.

      The exclusion criteria include open fractures, fractures with concomitant vascular or
      neurologic deficit, any fracture requiring open reduction, pathologic fractures, those
      presenting with concomitant injuries, swelling requiring post-operative hospitalization for
      monitoring, any known history of allergies to acetaminophen, ibuprofen or oxycodone, and
      patients with developmental delay that would preclude participation in the visual analog
      Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to
      participate in the study, and assent will be obtained from patients when possible. If parents
      refuse participation in the study, the reason for refusal will be documented, and their
      child's care and post-operative protocol will be consistent with our typical protocol, which
      includes all 3 medications.

      All surgeries will be performed at our outpatient surgery center. The treating pediatric
      anesthesiologists will use a standardized anesthesia protocol. All patients will be under
      general anesthesia and will not receive any regional anesthetics or local anesthetics. All
      included patients will undergo closed reduction and percutaneous pinning using 2-3 pins
      placed either all laterally or medially and laterally by two pediatric orthopaedic surgeons
      (MS and RT). They will al be placed in posterior long arm splints thereafter and made
      non-weight bearing in that extremity. The patients will be transferred to our post-anesthesia
      care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed for before discharge
      home. Nursing staff will record the amount of pain medication provided in the PACU as well as
      the pre-discharge pain scores, as is our typical post-operative protocol.

      Prior to discharge, patients will be randomized to receiving acetaminophen for first-line
      medication (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day)
      with as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8
      hours as needed, max dose 40mg/kg/day) or acetaminophen for first-line medication (liquid
      oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) with as needed
      oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as
      needed). Each patient will receive 18 doses (3 days) of acetaminophen and the study
      medication. Pre-sealed, sequentially numbered randomization envelopes containing each
      subject's group will be delivered to the hospital pharmacy. Patients will be instructed to
      first take the labeled acetaminophen medication and to take the study medication (unlabeled)
      as needed for breakthrough pain as prescribed. Patients will be given both patient
      information for both study medications in order to keep the patients blinded to which study
      medication they received. They will be given patient information for both medications but
      told that they have been given only one of the two medications. Medication labels will be
      obscured by the pharmacist with a circumferential tape. Throughout the study, the
      investigators and the parents will be blinded as to which study medication was given to each
      participant. Parents who contact the physician (a resident physician on-call for the
      pediatric orthopaedic surgery service who is not involved in the study) post-operatively for
      alternative pain medication will be provided the study medication not initially provided
      (i.e. those that were randomized to receive oxycodone primarily will be provided ibuprofen
      and vice versa), as confirmed by our pharmacy.

      Post-operatively, the parents of each participant will be asked to use the Faces Pain
      Scale-Revised (FPS-R)16 to rate the child's level of pain at 24 hours and 48 hours after
      surgery. A research team member will call each participant's guardian at 24 and 48 hours
      post-operatively to collect these responses. Parents will further be asked to complete the
      modified Total Quality Pain Management Instrument (TQPM)17 regarding their level of
      satisfaction with surgery and post-operative pain control. Parents will be asked to report
      any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the
      medications. A take-home medication log will be utilized by the parents to record the type
      and amount of mediation given to each participant and to record any associated side effects.

      For breakthrough pain experienced during pharmacy hours the patient will have the option to
      return to our pharmacy to obtain the medication they were not originally prescribed. Though
      the investigators believe this will be unlikely, if they are unable to get to the pharmacy
      for the other medication (e.g. oxycodone if they were in the ibuprofen group or ibuprofen if
      they were in the oxycodone group), parents can go to the ER for IM/IV medication for pain
      relief and they can get a prescription for oxycodone or ibuprofen from the ER if necessary,
      once they contact the resident on call. There will always be a resident on call 24/7 to
      advise patients if they are unable to achieve adequate pain control with medications
      received. Again, the study group believes this will be an unlikely/rare event. The resident
      on call will have access to the study medication that the patient received. At this point,
      the resident on call can reveal what medication they were getting (in case they need a new
      prescription from the ER) so they do not get oxycodone if they were already prescribed
      oxycodone (and can get something different) or they have the option to obtain ibuprofen
      over-the-counter if they wish. Patients who need to get the other medication would be
      considered a "failure in treatment" and would not be analyzed together from the original
      group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blinded, randomized trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Randomization envelopes used to allocate treatment groups
measure: Faces Pain Scale-Revised (FPSR)
time frame: 24 to 48 hours post-operatively
description: Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable
measure: Total Quality Pain Management Instrument
time frame: 1 week at first post-operative follow-up
description: Questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions re: post-operative pain management including domains in pain experience, pain relief, adverse effects, future analgesic use. The majority of the questions are binary, but there are a few questions that include a mild, moderate, severe option. There is no numerical output, and the subscales are not combined.
measure: Pain medication logs
time frame: Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.
description: Self report take home medication logs recording the time, type, dosage, and side effects of medication
arm group label: Ibuprofen
arm group type: Experimental
description: This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day).
arm group label: Oxycodone
arm group type: Active Comparator
description: This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as needed).
intervention type: Drug
intervention name: Ibuprofen
description: Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
arm group label: Ibuprofen
other name: Advil, Motrin
intervention type: Drug
intervention name: Oxycodone
description: Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
arm group label: Oxycodone
other name: roxicodone
intervention type: Drug
intervention name: Acetaminophen
description: Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
arm group label: Ibuprofen
arm group label: Oxycodone
other name: Tylenol, Paracetamol
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Rachel M Thompson, MD
role: Principal Investigator
affiliation: UCLA/OIC
last name: Jared M Alswang
phone: 2137426537
email: jalswang@mednet.ucla.edu
last name: Christina K Sun, MS
phone: 2137421057
email: CKSun@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Rachel Thompson, MD
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Acetaminophen
mesh term: Ibuprofen
mesh term: Oxycodone
sharing ipd: No
provided document: 
provided document: 
provided document: 