Comparison Between Oral and Enema of Chloral Hydrate

Sun Yat-sen University

Status

Completed

Conditions

Congenital Cataract

Treatments

Drug: enema chloral hydrate

Drug: oral chloral hydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT03242629

CCPMOH2017-China-6

Details and patient eligibility

About

Full description

To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. The secondary endpoints included onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge.

Enrollment

120 patients

Sex

All

Ages

3 to 36 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg with American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion criteria

with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection bradycardia, and facial abnormalities, allergy to chloral hydrate, weight <2 or >20 kg .