Congenital Cataract
Conditions
Keywords
pediatric ophthalmic examination, chloral hydrate, Effects Comparison
Brief 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).
Detailed 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.
Interventions
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.
DRUGenema chloral hydrate
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 36 Months
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demography (age, sex, weight， laterality and medical history) | baseline | The demography of cataract and healthy children were recorded by using a semi-structured questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effect | the following 48 hour after using the drug | 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 |
| the time of Sleepiness:Onset time (min） | baseline | — |
| the time of Sleepiness:Duration of examination (min) | baseline | — |
| the time of Sleepiness:Recovery time (min) | baseline | — |
Outcome results
None listed