<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/NCT03018977</url>
  </required_header>
  <id_info>
    <org_study_id>ID125808</org_study_id>
    <nct_id>NCT03018977</nct_id>
  </id_info>
  <brief_title>Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT</brief_title>
  <official_title>Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ramathibodi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic&#xD;
      effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use&#xD;
      of the agents can lead to withdrawal symptoms when the drugs are weaned.&#xD;
&#xD;
      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and&#xD;
      younger age were the risk factors of withdrawal syndrome. Additional, some study showed the&#xD;
      sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide&#xD;
      standardized sedative weaning protocol including our hospital. The objectives in this study&#xD;
      are to establish the sedative weaning protocol and to compare the protocol sedative weaning&#xD;
      with the usual care weaning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in&#xD;
      PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation,&#xD;
      immobilization and synchronizing ventilatory support.&#xD;
&#xD;
      Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.&#xD;
&#xD;
      Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary&#xD;
      and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and&#xD;
      increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative&#xD;
      dose of medications and younger age were the risk factors of withdrawal syndrome. Additional,&#xD;
      some study showed the sedation protocol can reduce the incidence of withdrawal syndrome.&#xD;
      However, no worldwide standardized sedative weaning protocol including our hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of withdrawal symptom</measure>
    <time_frame>72 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of PICU stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sedation related adverse events</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Withdrawal Syndrome</condition>
  <arm_group>
    <arm_group_label>Sedative weaning protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We create the new sedative weaning protocol and then use the sedative weaning protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The sedative weaning protocol group</intervention_name>
    <description>After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.</description>
    <arm_group_label>Sedative weaning protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The usual group</intervention_name>
    <description>After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age&#xD;
&#xD;
          -  Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital&#xD;
&#xD;
          -  use analgesic/sedative drugs (parenteral)≥ 3 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom level of sedation or withdrawal assessment cannot be scored.&#xD;
&#xD;
          -  Patients transferred from other hospitals in which the patients have already presented&#xD;
             of withdrawal symptoms&#xD;
&#xD;
          -  patient/parent refuse this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Pediatric,Ramathibodi Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ramathibodi Hospital</investigator_affiliation>
    <investigator_full_name>Nattachai Anantasit</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypnotics and Sedatives</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03018977
org study id: ID125808
nct id: NCT03018977
lead sponsor: 
has dmc: Yes
Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic
      effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use
      of the agents can lead to withdrawal symptoms when the drugs are weaned.

      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and
      younger age were the risk factors of withdrawal syndrome. Additional, some study showed the
      sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide
      standardized sedative weaning protocol including our hospital. The objectives in this study
      are to establish the sedative weaning protocol and to compare the protocol sedative weaning
      with the usual care weaning.
Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in
      PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation,
      immobilization and synchronizing ventilatory support.

      Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.

      Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary
      and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and
      increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative
      dose of medications and younger age were the risk factors of withdrawal syndrome. Additional,
      some study showed the sedation protocol can reduce the incidence of withdrawal syndrome.
      However, no worldwide standardized sedative weaning protocol including our hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: incidence of withdrawal symptom
time frame: 72 hour
measure: length of PICU stay
time frame: 30 days
measure: sedation related adverse events
time frame: 7 days
arm group label: Sedative weaning protocol
arm group type: Active Comparator
description: We create the new sedative weaning protocol and then use the sedative weaning protocol.
arm group label: Usual Care
arm group type: Placebo Comparator
description: no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
intervention type: Other
intervention name: The sedative weaning protocol group
description: After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.
arm group label: Sedative weaning protocol
intervention type: Other
intervention name: The usual group
description: After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
arm group label: Usual Care
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Ramathibodi Hospital
investigator full name: Nattachai Anantasit
investigator title: Assistant Professor
mesh term: Substance Withdrawal Syndrome
mesh term: Hypnotics and Sedatives