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/NCT06035042</url>
    </required_header>
    <id_info>
      <org_study_id>2022-04821</org_study_id>
      <nct_id>NCT06035042</nct_id>
    </id_info>
    <brief_title>4P: Persistent Postoperative Pediatric Pain</brief_title>
    <acronym>4P</acronym>
    <official_title>4P: Persistent Postoperative Pediatric Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Halland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Lund University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Region Skane</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sahlgrenska University Hospital, Sweden</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Halland</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        For children, adequate perioperative pain management is a right according to the UN&#xD;
        convention on the rights of the child, a law in Sweden since 2020. Despite this, children are&#xD;
        still under-treated in many cases. In addition to great suffering, this can lead to missing&#xD;
        school and a long-term burden on the society.&#xD;
  &#xD;
        ESPA, the European Society for Pediatric Anesthesia, has drawn up guidelines for&#xD;
        perioperative pain management. With the study 4P: Persistent Postoperative Pediatric Pain, we&#xD;
        want to investigate whether these guidelines are followed and how many children develop&#xD;
        long-term pain postoperatively.&#xD;
  &#xD;
        In order to map the prevalence of pain after surgery in children in Sweden, the investigators&#xD;
        plan to include and follow 2000 children in southern Sweden who undergo surgery. The study&#xD;
        provides a unique opportunity to follow a large number of children, evaluate given per- and&#xD;
        postoperative pain treatment and identify factors linked to the development of acute and&#xD;
        long-term postoperative pain. Our goal is to optimize peri- and postoperative pediatric pain&#xD;
        management to promote rapid recovery after surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of acute postoperative pain</measure>
      <time_frame>Within 24 hours after surgery</time_frame>
      <description>How many children experience acute postoperative pain after surgery in Sweden?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to guidelines from ESPA regarding perioperative analgesia</measure>
      <time_frame>Perioperative</time_frame>
      <description>Are the suggested guidelines regarding pain treatment from ESPA followed and is that successful?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of persistent postoperative pain</measure>
      <time_frame>At 3 months after surgery</time_frame>
      <description>How many children experience persistent postoperative pain after surgery in Sweden?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of persistent postoperative pain</measure>
      <time_frame>At 6 months after surgery</time_frame>
      <description>How many children experience persistent postoperative pain after surgery in Sweden?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of persistent postoperative pain</measure>
      <time_frame>At 1 year after surgery</time_frame>
      <description>How many children experience persistent postoperative pain after surgery in Sweden?</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Do regional blocks influence the level of acute postoperative pain?</measure>
      <time_frame>Acute - within 24 hours.</time_frame>
      <description>Does the use of regional blocks affect acute postoperative pain?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Do regional blocks influence the level of persistent pain?</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Does the use of regional blocks affect persistent postoperative pain?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental stress</measure>
      <time_frame>Within 24 hours</time_frame>
      <description>Does the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of acute postoperative pain?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental stress</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>Does the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of persistent postoperative pain?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>Acute (24 hours) and persistent (3,6 months and 1 year)</time_frame>
      <description>Which age-groups experience most pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gender</measure>
      <time_frame>Acute (24 hours) and persistent (3,6 months and 1 year)</time_frame>
      <description>Do girls experience more pain than boys?</description>
    </secondary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Postoperative Pain</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Scheduled surgery</intervention_name>
      <description>All subjects will be exposed to surgery</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children with planned surgery in southern Sweden for by ESPA specified types of surgeries.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 1-17 years&#xD;
  &#xD;
            -  Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy,&#xD;
               appendectomy or acute fracture in southern Sweden.&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scheduled for several surgeries within the time-frame&#xD;
  &#xD;
            -  Inability to understand swedish&#xD;
  &#xD;
            -  Inability to understand the meaning of participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna KM Persson, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Region Halland</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna KM Persson, MD. PhD</last_name>
      <phone>+4635131676</phone>
      <email>anna.p.persson@regionhalland.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Johanna Broman, MD</last_name>
      <phone>+46705375109</phone>
      <email>johanna.broman@med.lu.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Queen Silvias Childrens Hospital Sahlgrenska University Hospital</name>
        <address>
          <city>Göteborg</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christian Bergek, MD</last_name>
        <phone>+46313438505</phone>
        <email>christian.bergek@vgregion.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hallands Hospital Halmstad</name>
        <address>
          <city>Halmstad</city>
          <zip>30572</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anna KM Persson, MD, PhD</last_name>
        <phone>+46703047160</phone>
        <email>anna.p.persson@regionhalland.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Helsingborgs Hospital</name>
        <address>
          <city>Helsingborg</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Johanna Broman</last_name>
        <phone>+46705375109</phone>
        <email>johanna.broman@med.lu.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lund childrens hospital</name>
        <address>
          <city>Lund</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Johanna Broman, MD</last_name>
        <phone>+46705375109</phone>
        <email>johanna.broman@med.lu.se</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Region Halland</investigator_affiliation>
      <investigator_full_name>Anna Persson</investigator_full_name>
      <investigator_title>MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine</investigator_title>
    </responsible_party>
    <keyword>Pediatric pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_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/NCT06035042
  org study id: 2022-04821
  nct id: NCT06035042
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For children, adequate perioperative pain management is a right according to the UN
        convention on the rights of the child, a law in Sweden since 2020. Despite this, children are
        still under-treated in many cases. In addition to great suffering, this can lead to missing
        school and a long-term burden on the society.
  
        ESPA, the European Society for Pediatric Anesthesia, has drawn up guidelines for
        perioperative pain management. With the study 4P: Persistent Postoperative Pediatric Pain, we
        want to investigate whether these guidelines are followed and how many children develop
        long-term pain postoperatively.
  
        In order to map the prevalence of pain after surgery in children in Sweden, the investigators
        plan to include and follow 2000 children in southern Sweden who undergo surgery. The study
        provides a unique opportunity to follow a large number of children, evaluate given per- and
        postoperative pain treatment and identify factors linked to the development of acute and
        long-term postoperative pain. Our goal is to optimize peri- and postoperative pediatric pain
        management to promote rapid recovery after surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of acute postoperative pain
  time frame: Within 24 hours after surgery
  description: How many children experience acute postoperative pain after surgery in Sweden?
  measure: Adherence to guidelines from ESPA regarding perioperative analgesia
  time frame: Perioperative
  description: Are the suggested guidelines regarding pain treatment from ESPA followed and is that successful?
  measure: Incidence of persistent postoperative pain
  time frame: At 3 months after surgery
  description: How many children experience persistent postoperative pain after surgery in Sweden?
  measure: Incidence of persistent postoperative pain
  time frame: At 6 months after surgery
  description: How many children experience persistent postoperative pain after surgery in Sweden?
  measure: Incidence of persistent postoperative pain
  time frame: At 1 year after surgery
  description: How many children experience persistent postoperative pain after surgery in Sweden?
  measure: Do regional blocks influence the level of acute postoperative pain?
  time frame: Acute - within 24 hours.
  description: Does the use of regional blocks affect acute postoperative pain?
  measure: Do regional blocks influence the level of persistent pain?
  time frame: 3 months after surgery
  description: Does the use of regional blocks affect persistent postoperative pain?
  measure: Parental stress
  time frame: Within 24 hours
  description: Does the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of acute postoperative pain?
  measure: Parental stress
  time frame: 3 months after surgery
  description: Does the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of persistent postoperative pain?
  measure: Age
  time frame: Acute (24 hours) and persistent (3,6 months and 1 year)
  description: Which age-groups experience most pain
  measure: Gender
  time frame: Acute (24 hours) and persistent (3,6 months and 1 year)
  description: Do girls experience more pain than boys?
  intervention type: Procedure
  intervention name: Scheduled surgery
  description: All subjects will be exposed to surgery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 17 Years
  healthy volunteers: No
  last name: Anna KM Persson, MD, PhD
  role: Principal Investigator
  affiliation: Region Halland
  last name: Anna KM Persson, MD. PhD
  phone: +4635131676
  email: anna.p.persson@regionhalland.se
  last name: Johanna Broman, MD
  phone: +46705375109
  email: johanna.broman@med.lu.se
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Region Halland
  investigator full name: Anna Persson
  investigator title: MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine
  mesh term: Pain, Postoperative
  sharing ipd: No