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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intraocular Pressure, Anesthesia

Intervention / Treatment
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* Other: Intraocular pressure evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraocular pressure evaluation<br>Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete | Other: Intraocular pressure evaluation<br>* Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.<br>|
| Safety of sedation<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure during chloral hydrate sedation | Unit- mmHg | 25 minutes after sedation to 125 minutes after sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chloral hydrate dose required for successful sedation | Unit- mg | Adminstration to adequate sedation (up to 30 minutes) | 
| Time to recovery | Unit- minutes | Sedation induction to 125 minutes after sedation | 
| Hear rate under sedation | Unit- beats per minute | Sedation induction to 125 minutes after sedation | 
| Blood pressure under sedation | Unit- mmHg | Sedation induction to 125 minutes after sedation | 
| Oxygen saturation under sedation | Unit- % | Sedation induction to 125 minutes after sedation | 
| Adverse events related to chloral hydrate 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 | Sedation induction to 125 minutes after sedation |