xml: <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/NCT06023043</url>
    </required_header>
    <id_info>
      <org_study_id>CHLA-23-00124</org_study_id>
      <nct_id>NCT06023043</nct_id>
    </id_info>
    <brief_title>Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients</brief_title>
    <official_title>A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital 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 goal of this randomized clinical trial is to compare the immediate use of steroids after&#xD;
        surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular&#xD;
        scoliosis after a posterior spinal fusion.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
          -  What are the effects of using steroids immediately after surgery in decreasing opioid&#xD;
             use and helping early mobilization(movement)?&#xD;
  &#xD;
          -  Does post-operative steroid use affect the incidence of wound complications and are&#xD;
             there any long-term impacts on scar formation?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey&#xD;
             specifically for pain interference and physical activity observing health related&#xD;
             quality of life at enrollment, 3 months, 1 year, and 2 years&#xD;
  &#xD;
          -  Have clinical photos of their incision at 3 months, 1 year, and 2 years&#xD;
  &#xD;
               -  Their photos will be assessed using the stony book scar evaluation scale&#xD;
  &#xD;
          -  For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF)&#xD;
             per standard of care, however whether the participant receives or does not receive&#xD;
             steroids is what the investigators are trying to understand.&#xD;
  &#xD;
          -  Researchers will compare no immediate postoperative steroid (NS) to the group with&#xD;
             immediate postoperative steroid (WS) group to see if there are changes in opioid use,&#xD;
             wound complications, scar formation, and facilitation in early mobilization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children remain a vulnerable population historically known to be undertreated and&#xD;
        underrecognized for their pain, only perpetuating the complexity of managing pain control in&#xD;
        this cohort. Children's Hospital of Los Angeles conducted a study observing patient and&#xD;
        family's perioperative perception regarding their posterior spinal fusion and found that pain&#xD;
        control is a primary concern, however, surgeons did not share the sentiment. Opioids were&#xD;
        primarily the medication of choice with dentists and surgeons accounting for approximately&#xD;
        two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and&#xD;
        its adverse effects not limited to addiction, providers are gravitating towards alternative&#xD;
        multidisciplinary use of medication to manage pain.&#xD;
  &#xD;
        Though steroids were formerly used for surgical patients, concerns regarding increased&#xD;
        surgical site infection and wound healing complications were of major concern. However, to&#xD;
        the investigators knowledge, these issues have only been documented with chronic steroid use.&#xD;
        The impact of immediate use of steroids postoperatively for accelerated discharge has gained&#xD;
        momentum in the literature with its demonstration in facilitating earlier mobility, decreased&#xD;
        pain scores, and decreased narcotic usage. A retrospective study suggested that&#xD;
        post-operative dexamethasone administration can have the positive effect of reducing opioid&#xD;
        use in pediatric PSF patients without increasing wound complications.&#xD;
  &#xD;
        The proposed study aims to rigorously observe the effects of post operative steroid use in&#xD;
        its facilitation in early mobilization in adolescent PSF patients, while also understanding&#xD;
        the incidence of wound complications and long-term scar formation. Should the randomized&#xD;
        controlled trial align with the literature, the implementation of post-operative steroids&#xD;
        could potentially alter standard of care for adolescent PSF patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Length of Stay</measure>
      <time_frame>From date of hospitalization for surgery until date of first discharge, assessed up to two weeks</time_frame>
      <description>Day/hours to discharge from hospital following completion of surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post Operative Opioid Use</measure>
      <time_frame>From date of hospitalization for surgery until date of first discharge, assessed up to two weeks</time_frame>
      <description>Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post Operative Ambulation (for ambulatory patients)</measure>
      <time_frame>From date of hospitalization for surgery until date of first discharge, assessed up to two weeks</time_frame>
      <description>Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return of Bowel Function</measure>
      <time_frame>From date of hospitalization for surgery until date of first discharge, assessed up to two weeks</time_frame>
      <description>Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of wound complications requiring intervention</measure>
      <time_frame>Less than 90 days from hospitalization</time_frame>
      <description>3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scar Appearance</measure>
      <time_frame>Immediately from enrollment through study completion, at an average of 2 years</time_frame>
      <description>Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale.&#xD;
  The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
      <time_frame>Immediately from enrollment through study completion, at an average of 2 years</time_frame>
      <description>The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so.&#xD;
  PROMIS domains that will be utilized include:&#xD;
  pain interference&#xD;
  A five-point Likert scale ranging from 1 (&quot;never&quot;) to 5 (&quot;almost always&quot;) is used.&#xD;
  A higher score is indicative of more problems with pain hindering activities than a lower score.&#xD;
  physical activity&#xD;
  A five-point Likert scale ranging from 1 (&quot;never&quot;) to 5 (&quot;almost always&quot;) is used.&#xD;
  A higher score is indicative of engagement with more physical activities than a lower score.&#xD;
  mobility&#xD;
  A five-point Likert scale ranging from 1 (&quot;never&quot;) to 5 (&quot;almost always&quot;) is used.&#xD;
  A higher score is indicative of engagement with more mobility than a lower score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-Operative Complications</measure>
      <time_frame>Within 2 years from date of surgery.</time_frame>
      <description>Any additional emergency room visits/readmission or revision surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>Immediately from enrollment through study completion, at an average of 2 years</time_frame>
      <description>Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Neuromuscular Scoliosis</condition>
    <condition>Adolescent Idiopathic Scoliosis</condition>
    <arm_group>
      <arm_group_label>No Steroid (NS)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No Dexamethasone (NS)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>With Steroid (WS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>With Dexamethasone (WS)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)</description>
      <arm_group_label>With Steroid (WS)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants must meet all of the inclusion criteria to participate in this study:&#xD;
  &#xD;
          • Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat&#xD;
          AIS or NMS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded if any of the following criteria are met at baseline:&#xD;
  &#xD;
            -  Prior instrumentation or spine surgery&#xD;
  &#xD;
            -  Conditions associated with increased wound healing issues such as spina bifida&#xD;
  &#xD;
            -  Non AIS or NMS patients&#xD;
  &#xD;
            -  Not undergoing PSF&#xD;
  &#xD;
            -  Outside the ages of 9-18&#xD;
  &#xD;
            -  Allergies to the steroids and/or their ingredients&#xD;
  &#xD;
            -  Current drug or alcohol use or dependence that, in the opinion of the site&#xD;
               investigator, would interfere with adherence to study requirements&#xD;
  &#xD;
            -  Inability or unwillingness of individual or legal guardian/representative to give&#xD;
               written informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lindsay Andras, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Hospital Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lindsay M Andras, MD</last_name>
      <phone>323-361-2142</phone>
      <email>landras@chla.usc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tiffany Phan, BA</last_name>
      <email>tphan@chla.usc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital Los Angeles</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90027</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tiffany Phan</last_name>
        <phone>310-848-8377</phone>
        <email>tphan@chla.usc.edu</email>
      </contact>
      <investigator>
        <last_name>Lindsay Andras, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.</citation>
      <PMID>27927519</PMID>
    </reference>
    <reference>
      <citation>Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.</citation>
      <PMID>33093753</PMID>
    </reference>
    <reference>
      <citation>Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.</citation>
      <PMID>33086348</PMID>
    </reference>
    <reference>
      <citation>Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.</citation>
      <PMID>24809068</PMID>
    </reference>
    <reference>
      <citation>Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.</citation>
      <PMID>25554755</PMID>
    </reference>
    <reference>
      <citation>Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.</citation>
      <PMID>34400573</PMID>
    </reference>
    <reference>
      <citation>Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.</citation>
      <PMID>30889145</PMID>
    </reference>
    <reference>
      <citation>Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.</citation>
      <PMID>28263228</PMID>
    </reference>
    <results_reference>
      <citation>Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.</citation>
      <PMID>24770995</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
      <investigator_full_name>Lindsay Andras</investigator_full_name>
      <investigator_title>Associate Division Chief and Director of the Spine Program</investigator_title>
    </responsible_party>
    <keyword>Steroid</keyword>
    <keyword>Dexamethasone</keyword>
    <keyword>Scoliosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023043
  org study id: CHLA-23-00124
  nct id: NCT06023043
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this randomized clinical trial is to compare the immediate use of steroids after
        surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular
        scoliosis after a posterior spinal fusion.
  
        The main question it aims to answer are:
  
          -  What are the effects of using steroids immediately after surgery in decreasing opioid
             use and helping early mobilization(movement)?
  
          -  Does post-operative steroid use affect the incidence of wound complications and are
             there any long-term impacts on scar formation?
  
        Participants will:
  
          -  Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey
             specifically for pain interference and physical activity observing health related
             quality of life at enrollment, 3 months, 1 year, and 2 years
  
          -  Have clinical photos of their incision at 3 months, 1 year, and 2 years
  
               -  Their photos will be assessed using the stony book scar evaluation scale
  
          -  For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF)
             per standard of care, however whether the participant receives or does not receive
             steroids is what the investigators are trying to understand.
  
          -  Researchers will compare no immediate postoperative steroid (NS) to the group with
             immediate postoperative steroid (WS) group to see if there are changes in opioid use,
             wound complications, scar formation, and facilitation in early mobilization.
  Children remain a vulnerable population historically known to be undertreated and
        underrecognized for their pain, only perpetuating the complexity of managing pain control in
        this cohort. Children's Hospital of Los Angeles conducted a study observing patient and
        family's perioperative perception regarding their posterior spinal fusion and found that pain
        control is a primary concern, however, surgeons did not share the sentiment. Opioids were
        primarily the medication of choice with dentists and surgeons accounting for approximately
        two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and
        its adverse effects not limited to addiction, providers are gravitating towards alternative
        multidisciplinary use of medication to manage pain.
  
        Though steroids were formerly used for surgical patients, concerns regarding increased
        surgical site infection and wound healing complications were of major concern. However, to
        the investigators knowledge, these issues have only been documented with chronic steroid use.
        The impact of immediate use of steroids postoperatively for accelerated discharge has gained
        momentum in the literature with its demonstration in facilitating earlier mobility, decreased
        pain scores, and decreased narcotic usage. A retrospective study suggested that
        post-operative dexamethasone administration can have the positive effect of reducing opioid
        use in pediatric PSF patients without increasing wound complications.
  
        The proposed study aims to rigorously observe the effects of post operative steroid use in
        its facilitation in early mobilization in adolescent PSF patients, while also understanding
        the incidence of wound complications and long-term scar formation. Should the randomized
        controlled trial align with the literature, the implementation of post-operative steroids
        could potentially alter standard of care for adolescent PSF patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Length of Stay
  time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
  description: Day/hours to discharge from hospital following completion of surgery.
  measure: Post Operative Opioid Use
  time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
  description: Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
  measure: Post Operative Ambulation (for ambulatory patients)
  time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
  description: Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
  measure: Return of Bowel Function
  time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
  description: Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
  measure: Rate of wound complications requiring intervention
  time frame: Less than 90 days from hospitalization
  description: 3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
  measure: Scar Appearance
  time frame: Immediately from enrollment through study completion, at an average of 2 years
  description: Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale.
  The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
  measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
  time frame: Immediately from enrollment through study completion, at an average of 2 years
  description: The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so.
  PROMIS domains that will be utilized include:
  pain interference
  A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
  A higher score is indicative of more problems with pain hindering activities than a lower score.
  physical activity
  A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
  A higher score is indicative of engagement with more physical activities than a lower score.
  mobility
  A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
  A higher score is indicative of engagement with more mobility than a lower score.
  measure: Post-Operative Complications
  time frame: Within 2 years from date of surgery.
  description: Any additional emergency room visits/readmission or revision surgery
  measure: Body Mass Index
  time frame: Immediately from enrollment through study completion, at an average of 2 years
  description: Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2
  arm group label: No Steroid (NS)
  arm group type: No Intervention
  description: No Dexamethasone (NS)
  arm group label: With Steroid (WS)
  arm group type: Experimental
  description: With Dexamethasone (WS)
  intervention type: Drug
  intervention name: Dexamethasone
  description: Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)
  arm group label: With Steroid (WS)
  criteria: 
  gender: All
  minimum age: 9 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Lindsay Andras, MD
  role: Principal Investigator
  affiliation: Children's Hospital Los Angeles
  last name: Lindsay M Andras, MD
  phone: 323-361-2142
  email: landras@chla.usc.edu
  last name: Tiffany Phan, BA
  email: tphan@chla.usc.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
  PMID: 27927519
  citation: Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.
  PMID: 33093753
  citation: Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.
  PMID: 33086348
  citation: Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
  PMID: 24809068
  citation: Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.
  PMID: 25554755
  citation: Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.
  PMID: 34400573
  citation: Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.
  PMID: 30889145
  citation: Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.
  PMID: 28263228
  citation: Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.
  PMID: 24770995
  responsible party type: Principal Investigator
  investigator affiliation: Children's Hospital Los Angeles
  investigator full name: Lindsay Andras
  investigator title: Associate Division Chief and Director of the Spine Program
  mesh term: Scoliosis
  mesh term: Dexamethasone
  sharing ipd: No