Overview

The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible to obtain in an office setting. Children need sedation or general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Miami
Treatments:
Nitrous Oxide
Sevoflurane
Tetracaine
Criteria
Inclusion Criteria:

- male or female from 1 year of age to less than 18 years of age

- Out-patients scheduled to undergo examination under anesthesia

- out-patients scheduled to undergo eye surgery for strabismus or oculoplastic
procedure.

- ASA status I or II

- female patients who have attained menarche must have negative pregnancy tests at
screening

Exclusion Criteria:

- patients that have contraindications to the use of nitrous oxide in oxygen

- glaucoma patients

- patients in whom IOP cannot be measured accurately

- latex allergy patients

- patients allergic to aminoesthers