Effects Comparison Between Oral and Enema of Chloral Hydrate in Pediatric Ophthalmic Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Demography (age, sex, weight， laterality and medical history)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 .
研究组 & 干预措施
oral group
干预措施: oral chloral hydrate (Drug)
enema group
干预措施: enema chloral hydrate (Drug)
结局指标
主要结局
Demography (age, sex, weight， laterality and medical history)
时间窗: baseline
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire
次要结局
- Side effect(the following 48 hour after using the drug)
- 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)
研究者
Haotian Lin
Clinical Professor
Sun Yat-sen University