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An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children

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ClinicalTrials.gov Identifier: NCT02985567
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
King Khaled Eye Specialist Hospital
Information provided by (Responsible Party):
David S. Friedman, Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment
Intraocular Pressure Anesthesia Other: Intraocular pressure evaluation

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 324 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
Study Start Date : September 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intraocular pressure evaluation
Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete
Other: Intraocular pressure evaluation
Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.

Safety of sedation

Documentation of:

  1. The need for repeat dosing of chloral hydrate.
  2. The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge
  3. Interventions required for the patient including administration of oxygen, and need for intubation.



Primary Outcome Measures :
  1. Change in intraocular pressure during chloral hydrate sedation [ Time Frame: 25 minutes after sedation to 125 minutes after sedation ]
    Unit- mmHg


Secondary Outcome Measures :
  1. Chloral hydrate dose required for successful sedation [ Time Frame: Adminstration to adequate sedation (up to 30 minutes) ]
    Unit- mg

  2. Time to recovery [ Time Frame: Sedation induction to 125 minutes after sedation ]
    Unit- minutes

  3. Hear rate under sedation [ Time Frame: Sedation induction to 125 minutes after sedation ]
    Unit- beats per minute

  4. Blood pressure under sedation [ Time Frame: Sedation induction to 125 minutes after sedation ]
    Unit- mmHg

  5. Oxygen saturation under sedation [ Time Frame: Sedation induction to 125 minutes after sedation ]
    Unit- %

  6. Adverse events related to chloral hydrate sedation [ Time Frame: Sedation induction to 125 minutes after sedation ]
    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



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 1 month to five years requiring sedation for ophthalmic care at King Khaled Eye Specialist Hospital (KKESH).
Criteria

Inclusion Criteria:

  • ages 1 month to five years
  • require sedation for ophthalmic care

Exclusion Criteria:

  • weight <3 kg or >20 kg
  • infection/ocular surface disease
  • medical contraindication of chloral hydrate
  • green or gray nasal discharge
  • fever, productive cough, chest retractions, or other signs of respiratory infection
  • oxygen saturation < 90%
  • active infectious disease such as rubella or varicella
  • rectal or tympanic temperature > 37.7 degrees, or oral or temporal artery temperature > 37.2 degrees
  • history of current ongoing vomiting and diarrhea
  • anemia (Hgb < 9.0mg),
  • history of seizure in past 6 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985567


Locations
Saudi Arabia
King Khaled Eye Specialist Hospital (KKESH)
Riyadh, Saudi Arabia, 12329
Sponsors and Collaborators
Johns Hopkins University
King Khaled Eye Specialist Hospital
Investigators
Principal Investigator: David S Friedman, MD, MPH, PhD Johns Hopkins University

Publications:
Responsible Party: David S. Friedman, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02985567     History of Changes
Other Study ID Numbers: 00086598
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs