Comparison Between Oral and Enema of Chloral Hydrate
- Conditions
- Congenital Cataract
- Interventions
- Registration Number
- NCT03242629
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral group oral chloral hydrate - enema group enema chloral hydrate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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