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

NCT02985567 | Completed DMC

• 1 other identifier: 00086598
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in intraocular pressure during chloral hydrate sedation

  Unit- mmHg

  25 minutes after sedation to 125 minutes after sedation

Secondary Outcomes (6)

• Chloral hydrate dose required for successful sedation

  Adminstration to adequate sedation (up to 30 minutes)

• Time to recovery

  Sedation induction to 125 minutes after sedation

• Hear rate under sedation

  Sedation induction to 125 minutes after sedation

• Blood pressure under sedation

  Sedation induction to 125 minutes after sedation

• Oxygen saturation under sedation

  Sedation induction to 125 minutes after sedation

Study Arms (2)

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

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.

Interventions

Intraocular pressure evaluation OTHER

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

Intraocular pressure evaluation

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• ages 1 month to five years
• require sedation for ophthalmic care

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• King Khaled Eye Specialist Hospital: collaborator

Study Sites (1)

King Khaled Eye Specialist Hospital (KKESH)

Riyadh, Riyadh Region, 12329, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 7676990 BACKGROUND

• 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.

  PMID: 20032023 BACKGROUND

Study Officials

• David S Friedman, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 7, 2016
• Study Start: September 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)