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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
120
Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.
Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.
Demography (age, sex, weight， laterality and medical history)
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire
Time frame: baseline
Side effect
record the following symptom: Vomit after administration、Cough、SpO2 \< 95%、SpO2 \< 90%、New vomiting、Resume normal activity over 8 hour、Poor appetite、Altered bowel habit
Time frame: the following 48 hour after using the drug
the time of Sleepiness:Onset time (min）
Time frame: baseline
the time of Sleepiness:Duration of examination (min)
Time frame: baseline
the time of Sleepiness:Recovery time (min)
Time frame: baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.