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

NCT ID: NCT02985567

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-11-30

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.

Conditions

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Intraocular Pressure Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraocular pressure evaluation

Intraocular pressure evaluation using Icare tonometer 25 minutes after sedation, and then every 10 minutes until sedation is complete

Intraocular pressure evaluation

Intervention Type OTHER

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:

1. The need for repeat dosing of chloral hydrate.
2. The level of alertness of the patient at the end of sedation and the total time between induction and readiness for discharge
3. Interventions required for the patient including administration of oxygen, and need for intubation.

No interventions assigned to this group

Interventions

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Intraocular pressure evaluation

Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.

Intervention Type OTHER

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Khaled Eye Specialist Hospital

OTHER_GOV

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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David S. Friedman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Friedman, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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King Khaled Eye Specialist Hospital (KKESH)

Riyadh, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 7676990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20032023 (View on PubMed)

Other Identifiers

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00086598

Identifier Type: -

Identifier Source: org_study_id