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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985567
• Other study ID #: 00086598
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: December 5, 2016
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Intraocular Pressure

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Khaled Eye Specialist Hospital (KKESH)	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	King Khaled Eye Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intraocular pressure during chloral hydrate sedation	Unit- mmHg	25 minutes after sedation to 125 minutes after sedation	No
Secondary	Chloral hydrate dose required for successful sedation	Unit- mg	Adminstration to adequate sedation (up to 30 minutes)	No
Secondary	Time to recovery	Unit- minutes	Sedation induction to 125 minutes after sedation	No
Secondary	Hear rate under sedation	Unit- beats per minute	Sedation induction to 125 minutes after sedation	No
Secondary	Blood pressure under sedation	Unit- mmHg	Sedation induction to 125 minutes after sedation	No
Secondary	Oxygen saturation under sedation	Unit- %	Sedation induction to 125 minutes after sedation	No
Secondary	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	No