<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/NCT02985567</url>
  </required_header>
  <id_info>
    <org_study_id>00086598</org_study_id>
    <nct_id>NCT02985567</nct_id>
  </id_info>
  <brief_title>An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children</brief_title>
  <official_title>An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Khaled Eye Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study involves a prospective evaluation of chloral hydrate sedation for the measurement&#xD;
      of intraocular pressure in children ages one month to five years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, non-randomized trial of children 1 month to 5 years of age&#xD;
      who are determined to require a sedation procedure at the King Khaled Eye Specialist Hospital&#xD;
      (KKESH). There will be two parts to the consent process. Oral consent will be administered to&#xD;
      subjects who are not undergoing eye pressure evaluation. These children have chloral hydrate&#xD;
      sedation for imaging or other eye evaluations. For these children, we will prospectively&#xD;
      monitor the success rate of chloral hydrate sedation such that a complete ophthalmic or&#xD;
      imaging evaluation could be performed and will determine the proportion of adverse events&#xD;
      that occur due to sedation including vomiting, respiratory distress or depression,&#xD;
      alterations in vital signs beyond reference ranges for normal sleeping children, hypoxia with&#xD;
      oxygen saturation &lt;90%, and unplanned hospital admission. No testing will be performed for&#xD;
      study purposes on these individuals.&#xD;
&#xD;
      For children undergoing sedation who will have intraocular pressure measurements for clinical&#xD;
      care purposes, we will perform additional eye pressure measurements as part of the research&#xD;
      protocol. Written consent will be obtained to allow us to additionally measure their&#xD;
      intraocular pressure as specified below.&#xD;
&#xD;
      After recruitment and completion of informed consent procedures by parents, subjects' medical&#xD;
      and ocular history will be reviewed by a study ophthalmologist and one of two pediatricians&#xD;
      overseeing sedation procedures. Patients unable to undergo intraocular pressure measurement&#xD;
      due to infection or ocular surface disease and those in whom chloral hydrate sedation is&#xD;
      medically contraindicated will be excluded. Age, gender, diagnosis, current medications and&#xD;
      surgical history will be recorded from the clinical chart for all subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Change in intraocular pressure during chloral hydrate sedation</measure>
    <time_frame>25 minutes after sedation to 125 minutes after sedation</time_frame>
    <description>Unit- mmHg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chloral hydrate dose required for successful sedation</measure>
    <time_frame>Adminstration to adequate sedation (up to 30 minutes)</time_frame>
    <description>Unit- mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recovery</measure>
    <time_frame>Sedation induction to 125 minutes after sedation</time_frame>
    <description>Unit- minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hear rate under sedation</measure>
    <time_frame>Sedation induction to 125 minutes after sedation</time_frame>
    <description>Unit- beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure under sedation</measure>
    <time_frame>Sedation induction to 125 minutes after sedation</time_frame>
    <description>Unit- mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation under sedation</measure>
    <time_frame>Sedation induction to 125 minutes after sedation</time_frame>
    <description>Unit- %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to chloral hydrate sedation</measure>
    <time_frame>Sedation induction to 125 minutes after sedation</time_frame>
    <description>Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">324</enrollment>
  <condition>Intraocular Pressure</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Intraocular pressure evaluation</arm_group_label>
    <description>Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety of sedation</arm_group_label>
    <description>Documentation of:&#xD;
The need for repeat dosing of chloral hydrate.&#xD;
The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge&#xD;
Interventions required for the patient including administration of oxygen, and need for intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intraocular pressure evaluation</intervention_name>
    <description>Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.</description>
    <arm_group_label>Intraocular pressure evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 1 month to five years requiring sedation for ophthalmic care at King Khaled&#xD;
        Eye Specialist Hospital (KKESH).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 1 month to five years&#xD;
&#xD;
          -  require sedation for ophthalmic care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  weight &lt;3 kg or &gt;20 kg&#xD;
&#xD;
          -  infection/ocular surface disease&#xD;
&#xD;
          -  medical contraindication of chloral hydrate&#xD;
&#xD;
          -  green or gray nasal discharge&#xD;
&#xD;
          -  fever, productive cough, chest retractions, or other signs of respiratory infection&#xD;
&#xD;
          -  oxygen saturation &lt; 90%&#xD;
&#xD;
          -  active infectious disease such as rubella or varicella&#xD;
&#xD;
          -  rectal or tympanic temperature &gt; 37.7 degrees, or oral or temporal artery temperature&#xD;
             &gt; 37.2 degrees&#xD;
&#xD;
          -  history of current ongoing vomiting and diarrhea&#xD;
&#xD;
          -  anemia (Hgb &lt; 9.0mg),&#xD;
&#xD;
          -  history of seizure in past 6 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David S Friedman, MD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Khaled Eye Specialist Hospital (KKESH)</name>
      <address>
        <city>Riyadh</city>
        <zip>12329</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Vade A, Sukhani R, Dolenga M, Habisohn-Schuck C. Chloral hydrate sedation of children undergoing CT and MR imaging: safety as judged by American Academy of Pediatrics guidelines. AJR Am J Roentgenol. 1995 Oct;165(4):905-9. doi: 10.2214/ajr.165.4.7676990.</citation>
    <PMID>7676990</PMID>
  </reference>
  <reference>
    <citation>Litman RS, Soin K, Salam A. Chloral hydrate sedation in term and preterm infants: an analysis of efficacy and complications. Anesth Analg. 2010 Mar 1;110(3):739-46. doi: 10.1213/ANE.0b013e3181ca12a8. Epub 2009 Dec 23.</citation>
    <PMID>20032023</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>David S. Friedman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT02985567
org study id: 00086598
nct id: NCT02985567
lead sponsor: 
collaborator: 
has dmc: Yes
The study involves a prospective evaluation of chloral hydrate sedation for the measurement
      of intraocular pressure in children ages one month to five years of age.
This study will be a prospective, non-randomized trial of children 1 month to 5 years of age
      who are determined to require a sedation procedure at the King Khaled Eye Specialist Hospital
      (KKESH). There will be two parts to the consent process. Oral consent will be administered to
      subjects who are not undergoing eye pressure evaluation. These children have chloral hydrate
      sedation for imaging or other eye evaluations. For these children, we will prospectively
      monitor the success rate of chloral hydrate sedation such that a complete ophthalmic or
      imaging evaluation could be performed and will determine the proportion of adverse events
      that occur due to sedation including vomiting, respiratory distress or depression,
      alterations in vital signs beyond reference ranges for normal sleeping children, hypoxia with
      oxygen saturation <90%, and unplanned hospital admission. No testing will be performed for
      study purposes on these individuals.

      For children undergoing sedation who will have intraocular pressure measurements for clinical
      care purposes, we will perform additional eye pressure measurements as part of the research
      protocol. Written consent will be obtained to allow us to additionally measure their
      intraocular pressure as specified below.

      After recruitment and completion of informed consent procedures by parents, subjects' medical
      and ocular history will be reviewed by a study ophthalmologist and one of two pediatricians
      overseeing sedation procedures. Patients unable to undergo intraocular pressure measurement
      due to infection or ocular surface disease and those in whom chloral hydrate sedation is
      medically contraindicated will be excluded. Age, gender, diagnosis, current medications and
      surgical history will be recorded from the clinical chart for all subjects.
observational model: Cohort
time perspective: Prospective
measure: Change in intraocular pressure during chloral hydrate sedation
time frame: 25 minutes after sedation to 125 minutes after sedation
description: Unit- mmHg
measure: Chloral hydrate dose required for successful sedation
time frame: Adminstration to adequate sedation (up to 30 minutes)
description: Unit- mg
measure: Time to recovery
time frame: Sedation induction to 125 minutes after sedation
description: Unit- minutes
measure: Hear rate under sedation
time frame: Sedation induction to 125 minutes after sedation
description: Unit- beats per minute
measure: Blood pressure under sedation
time frame: Sedation induction to 125 minutes after sedation
description: Unit- mmHg
measure: Oxygen saturation under sedation
time frame: Sedation induction to 125 minutes after sedation
description: Unit- %
measure: Adverse events related to chloral hydrate sedation
time frame: Sedation induction to 125 minutes after sedation
description: Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest Unit- number of events (that occur from the following list) Vomiting, subclinical respiratory depression, recovery agitation, oxygen desaturation, airway obstruction, failed sedation, bradycardia, tachycardia, hypotension, hypertension, seizure, aspiration, apnea, arrhythmia, cardiac arrest
arm group label: Intraocular pressure evaluation
description: Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete
arm group label: Safety of sedation
description: Documentation of:
The need for repeat dosing of chloral hydrate.
The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge
Interventions required for the patient including administration of oxygen, and need for intubation.
intervention type: Other
intervention name: Intraocular pressure evaluation
description: Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.
arm group label: Intraocular pressure evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 5 Years
healthy volunteers: No
last name: David S Friedman, MD, MPH, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: Saudi Arabia
citation: Vade A, Sukhani R, Dolenga M, Habisohn-Schuck C. Chloral hydrate sedation of children undergoing CT and MR imaging: safety as judged by American Academy of Pediatrics guidelines. AJR Am J Roentgenol. 1995 Oct;165(4):905-9. doi: 10.2214/ajr.165.4.7676990.
PMID: 7676990
citation: Litman RS, Soin K, Salam A. Chloral hydrate sedation in term and preterm infants: an analysis of efficacy and complications. Anesth Analg. 2010 Mar 1;110(3):739-46. doi: 10.1213/ANE.0b013e3181ca12a8. Epub 2009 Dec 23.
PMID: 20032023
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: David S. Friedman
investigator title: Professor
sharing ipd: No