Comparison Between Oral and Enema of Chloral Hydrate

Congenital Cataract Clinical Trial

Official title: Effects Comparison Between Oral and Enema of Chloral Hydrate in Pediatric Ophthalmic Examination

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

• NCT number: NCT03242629
• Study type: Interventional
• Source: Sun Yat-sen University
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: July 2017