<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/NCT03242629</url>
  </required_header>
  <id_info>
    <org_study_id>CCPMOH2017-China-6</org_study_id>
    <nct_id>NCT03242629</nct_id>
  </id_info>
  <brief_title>Comparison Between Oral and Enema of Chloral Hydrate</brief_title>
  <official_title>Effects Comparison Between Oral and Enema of Chloral Hydrate in Pediatric Ophthalmic Examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the clinical sedative effect and safety using 10% chloral hydrate during&#xD;
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two&#xD;
      groups (oral group and enema group) using a computer random number generator with a 1:1&#xD;
      allocation (simple randomization, odd number for oral group and even number for enema group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare the clinical sedative effect and safety using 10% chloral hydrate during&#xD;
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two&#xD;
      groups (oral group and enema group) using a computer random number generator with a 1:1&#xD;
      allocation (simple randomization, odd number for oral group and even number for enema&#xD;
      group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to&#xD;
      ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or&#xD;
      enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to&#xD;
      complete the examinations including slit-lamp photography, tonometry, anterior segment&#xD;
      analysis, and refractive error inspection. The secondary endpoints included onset time,&#xD;
      duration of examination, recovery time, discharge time, any side effects during examination,&#xD;
      and within 48 h after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demography (age, sex, weight， laterality and medical history)</measure>
    <time_frame>baseline</time_frame>
    <description>The demography of cataract and healthy children were recorded by using a semi-structured questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effect</measure>
    <time_frame>the following 48 hour after using the drug</time_frame>
    <description>record the following symptom: Vomit after administration、Cough、SpO2 &lt; 95%、SpO2 &lt; 90%、New vomiting、Resume normal activity over 8 hour、Poor appetite、Altered bowel habit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time of Sleepiness:Onset time (min）</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time of Sleepiness:Duration of examination (min)</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time of Sleepiness:Recovery time (min)</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Congenital Cataract</condition>
  <arm_group>
    <arm_group_label>oral group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>enema group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral chloral hydrate</intervention_name>
    <description>Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.</description>
    <arm_group_label>oral group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>enema chloral hydrate</intervention_name>
    <description>Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.</description>
    <arm_group_label>enema group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg&#xD;
             with American Society of Anesthesiologists (ASA) physical status 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent&#xD;
             pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection&#xD;
             bradycardia, and facial abnormalities, allergy to chloral hydrate, weight &lt;2 or &gt;20 kg&#xD;
             .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haotian Lin, M.D,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Haotian Lin</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>pediatric ophthalmic examination</keyword>
  <keyword>chloral hydrate</keyword>
  <keyword>Effects Comparison</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloral Hydrate</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/NCT03242629
org study id: CCPMOH2017-China-6
nct id: NCT03242629
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the clinical sedative effect and safety using 10% chloral hydrate during
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two
      groups (oral group and enema group) using a computer random number generator with a 1:1
      allocation (simple randomization, odd number for oral group and even number for enema group).
To compare the clinical sedative effect and safety using 10% chloral hydrate during
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two
      groups (oral group and enema group) using a computer random number generator with a 1:1
      allocation (simple randomization, odd number for oral group and even number for enema
      group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to
      ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or
      enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to
      complete the examinations including slit-lamp photography, tonometry, anterior segment
      analysis, and refractive error inspection. The secondary endpoints included onset time,
      duration of examination, recovery time, discharge time, any side effects during examination,
      and within 48 h after discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Demography (age, sex, weight， laterality and medical history)
time frame: baseline
description: The demography of cataract and healthy children were recorded by using a semi-structured questionnaire
measure: Side effect
time frame: the following 48 hour after using the drug
description: record the following symptom: Vomit after administration、Cough、SpO2 < 95%、SpO2 < 90%、New vomiting、Resume normal activity over 8 hour、Poor appetite、Altered bowel habit
measure: the time of Sleepiness:Onset time (min）
time frame: baseline
measure: the time of Sleepiness:Duration of examination (min)
time frame: baseline
measure: the time of Sleepiness:Recovery time (min)
time frame: baseline
arm group label: oral group
arm group type: Active Comparator
arm group label: enema group
arm group type: Experimental
intervention type: Drug
intervention name: oral chloral hydrate
description: Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.
arm group label: oral group
intervention type: Drug
intervention name: enema chloral hydrate
description: Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.
arm group label: enema group
criteria: 
gender: All
minimum age: 3 Months
maximum age: 36 Months
healthy volunteers: No
last name: Haotian Lin, M.D,Ph.D
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Haotian Lin
investigator title: Clinical Professor
mesh term: Cataract
mesh term: Chloral Hydrate