Clinical trial NCT02985567: An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
Official title: An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Anesthesia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: King Khaled Eye Specialist Hospital
First posted: 2016-12-07
Enrollment: 324
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in intraocular pressure during chloral hydrate sedation
timeFrame: 25 minutes after sedation to 125 minutes after sedation
Secondary outcomes:
measure: Chloral hydrate dose required for successful sedation
timeFrame: Adminstration to adequate sedation (up to 30 minutes)
measure: Time to recovery
timeFrame: Sedation induction to 125 minutes after sedation
measure: Hear rate under sedation
timeFrame: Sedation induction to 125 minutes after sedation
measure: Blood pressure under sedation
timeFrame: Sedation induction to 125 minutes after sedation
measure: Oxygen saturation under sedation
timeFrame: Sedation induction to 125 minutes after sedation
measure: Adverse events related to chloral hydrate sedation
timeFrame: Sedation induction to 125 minutes after sedation
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khaled Eye Specialist Hospital (KKESH)
Study officials:
affiliation: Johns Hopkins University
name: David S Friedman, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.