<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/NCT02980549</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0116</org_study_id>
    <nct_id>NCT02980549</nct_id>
  </id_info>
  <brief_title>How Common Are Sleep Disorders and Problems With Emergence From Anesthesia in Surgical Patients</brief_title>
  <official_title>Determining the Incidence of Parasomnias (PS) and Emergence Delirium (ED)in the American Family Children's Hospital Patient Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is&#xD;
      defined as a dissociated state of consciousness, occurring on awakening from general&#xD;
      anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not&#xD;
      consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem&#xD;
      in pre-school children, with estimates of the incidence ranging from 10-70% of children in&#xD;
      this age group. These children are agitated, seemingly unaware of their surroundings, and&#xD;
      typically do not respond to parents or caregivers. They are therefore at risk for&#xD;
      self-inflicted traumatic injury and complications secondary to disruptions of intravenous&#xD;
      lines, surgical incisions, or drains. Children with ED typically require more resources in&#xD;
      the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED&#xD;
      would allow for better allocation of resources in the post-anesthetic care unit (PACU).&#xD;
&#xD;
      The peak incidence of ED in children occurs in the same age range at which the peak incidence&#xD;
      of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the&#xD;
      description of ED; the American Academy of Sleep Medicine defines parasomnias as &quot;undesirable&#xD;
      physical events or experiences that occur during entry into sleep, within sleep or during&#xD;
      arousals from sleep.&quot; Parasomnias can be diagnosed using a sleep questionnaire.&#xD;
&#xD;
      The purpose of this pilot study is to determine the incidence of ED and PS in our population,&#xD;
      in order to determine the number of patients necessary to enroll in a larger study to either&#xD;
      confirm or reject the hypothesis that ED and PS are correlated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Prevalence of parasomnias (PS) and emergence delirium (ED) in children</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>score on Childrens Sleep Habits Questionnaire correlated with ED</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Emergence Delirium</condition>
  <condition>Parasomnias</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>children's sleep habits questionnaire</intervention_name>
    <description>survey of children's sleep habits completed by parent</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred children age 1-6, ASA PS I or II, undergoing surgery by either elective&#xD;
        otolaryngology (ENT) (including but not limited to: tonsillectomy, adenoidectomy, and lymph&#xD;
        node biopsy) or elective urologic surgery (including but not limited to: circumcision,&#xD;
        cystoscopy and related procedures, orchidopexy or hernia), requiring intravenous line&#xD;
        placement, at American Family children's Hospital at the University of Wisconsin will be&#xD;
        enrolled in the study. The child's caregiver will complete a sleep questionnaire prior to&#xD;
        anesthesia and surgery. From the time the anesthetic is discontinued, after surgery, a&#xD;
        study coordinator will observe the child's emergence from anesthesia and rate emergence&#xD;
        using the PAED scale every 5 minutes until the child is awake.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery&#xD;
&#xD;
          2. ASA I or II&#xD;
&#xD;
          3. Presence of a caregiver who is familiar with the child's sleep history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Autism&#xD;
&#xD;
          2. Severe developmental delay&#xD;
&#xD;
          3. Children receiving clonidine&#xD;
&#xD;
          4. Medication for seizures&#xD;
&#xD;
          5. Children who have received ED treatment prior to a diagnosis of ED (clonidine,&#xD;
             dexmedetomidine, or propofol)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>May 5, 2015</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</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>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Parasomnias</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/NCT02980549
org study id: 2015-0116
nct id: NCT02980549
lead sponsor: 
has dmc: No
Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is
      defined as a dissociated state of consciousness, occurring on awakening from general
      anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not
      consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem
      in pre-school children, with estimates of the incidence ranging from 10-70% of children in
      this age group. These children are agitated, seemingly unaware of their surroundings, and
      typically do not respond to parents or caregivers. They are therefore at risk for
      self-inflicted traumatic injury and complications secondary to disruptions of intravenous
      lines, surgical incisions, or drains. Children with ED typically require more resources in
      the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED
      would allow for better allocation of resources in the post-anesthetic care unit (PACU).

      The peak incidence of ED in children occurs in the same age range at which the peak incidence
      of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the
      description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable
      physical events or experiences that occur during entry into sleep, within sleep or during
      arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.

      The purpose of this pilot study is to determine the incidence of ED and PS in our population,
      in order to determine the number of patients necessary to enroll in a larger study to either
      confirm or reject the hypothesis that ED and PS are correlated.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of parasomnias (PS) and emergence delirium (ED) in children
time frame: 6 months
measure: score on Childrens Sleep Habits Questionnaire correlated with ED
time frame: 6 months
intervention type: Other
intervention name: children's sleep habits questionnaire
description: survey of children's sleep habits completed by parent
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Parasomnias
sharing ipd: No