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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Anesthesia
• Intervention / Treatment: 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
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 12329
    • King Khaled Eye Specialist Hospital (KKESH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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: 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?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: King Khaled Eye Specialist Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 00086598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO