<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/NCT02995525</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBXSAR32016-02</org_study_id>
    <nct_id>NCT02995525</nct_id>
  </id_info>
  <brief_title>Chronic Pain After Scoliosis and Thoracic Surgery in Children</brief_title>
  <acronym>PEDIACHROII</acronym>
  <official_title>Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this epidemiologic prospective study is to determine the prevalence of CPSP&#xD;
      defined as pain occurring 4 months after scoliosis and thoracic surgery and rated &gt; 3 on a 10&#xD;
      point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.&#xD;
&#xD;
      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant&#xD;
      thoracic surgery in children aged 6 to 18 years.&#xD;
&#xD;
      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of&#xD;
      neuropathic syndrome and the predictive risk factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain at 4 months after surgery</measure>
    <time_frame>4 months after scoliosis and thoracic surgery in children aged 6 to 18 years</time_frame>
    <description>visual analogue scale for pain (0_100)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events after surgery</measure>
    <time_frame>adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)</time_frame>
    <description>infections, neurologic defect, new surgery, blood hematoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morphine consumption during the perioperative period</measure>
    <time_frame>the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)</time_frame>
    <description>morphine consumption (mg/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain during the perioperative period</measure>
    <time_frame>the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)</time_frame>
    <description>visual analogue scale for pain (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain during the perioperative period in disabled children aged 6 to 18 years</measure>
    <time_frame>the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)</time_frame>
    <description>FLACC scale level (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery</measure>
    <time_frame>2'4-48 h hours period after surgery, 4 months after surgery</time_frame>
    <description>DN4 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain at 4 months after surgery</measure>
    <time_frame>4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years</time_frame>
    <description>modified FLACC scale for pain</description>
  </secondary_outcome>
  <enrollment type="Actual">68</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>Scoliosis; Adolescence</condition>
  <condition>Pediatric ALL</condition>
  <condition>Chronic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric&#xD;
        Bordeaux hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in&#xD;
             paediatric Bordeaux hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who not willing to participate, with children and/or parental insufficient&#xD;
             understanding of the questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier Universitaire de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.</citation>
    <PMID>28077537</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</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>Scoliosis</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_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/NCT02995525
org study id: CHUBXSAR32016-02
nct id: NCT02995525
lead sponsor: 
has dmc: No
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP
      defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10
      point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant
      thoracic surgery in children aged 6 to 18 years.

      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of
      neuropathic syndrome and the predictive risk factors.
observational model: Case-Only
time perspective: Prospective
measure: pain at 4 months after surgery
time frame: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years
description: visual analogue scale for pain (0_100)
measure: adverse events after surgery
time frame: adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)
description: infections, neurologic defect, new surgery, blood hematoma
measure: morphine consumption during the perioperative period
time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
description: morphine consumption (mg/day)
measure: pain during the perioperative period
time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
description: visual analogue scale for pain (0-100)
measure: pain during the perioperative period in disabled children aged 6 to 18 years
time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
description: FLACC scale level (0-100)
measure: prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery
time frame: 2'4-48 h hours period after surgery, 4 months after surgery
description: DN4 questionnaire
measure: pain at 4 months after surgery
time frame: 4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years
description: modified FLACC scale for pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: France
citation: Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
PMID: 28077537
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Chronic Pain
sharing ipd: No