NCT02985567

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Month – 5 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Intraocular Pressure
• Anesthesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-12-07
• Last updated: 2016-12-07

Locations

1 site across 1 country: Saudi Arabia