A Randomised Comparison of Two Intranasal Dexmedetomidine Doses for Ophthalmic Examination Following Failed Chloral Hydrate Sedation in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numbers of participants with successful rescue sedation
研究概览
简要总结
2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children for ophthalmic examinations than the sedative effect of 1ug/kg.
详细描述
Dexmedetomidine is an a2-adrenergic receptor agonist that provides sedation without respiratory depression.Clinical trials have demonstrated that intranasal dexmedetomidine in a dose of 1ug/kg produces satisfactory sedation in between 53% and 57% of children at anaesthetic induction. There are also reports using higher doses of intranasal dexmedetomidine. The investigators compared the sedative effect of 1ug/kg intranasal dexmedetomidine with those of 2 ug/kg for ophthalmic examinations in children aged 2 months-10 years and hypothesised that the higher dose would produce satisfactory sedation in more children at the time of anaesthetic induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need sedation for ophthalmic examinations
- •Children who had failed chloral hydrate sedation, i.e.there was no evidence of sedation 30 min following administration.
- •With informed consent from parents
排除标准
- •Children with gastroesophageal reflux
- •Children with nausea and vomiting
- •Children with apnea in the past three months
- •Children with recent pneumonia, exacerbation of asthma, bronchitis and upper respiratory tract infection
- •Children with severe arrhythmias, heart failure and cardiac structural abnormalities
- •Children with facial abnormalities, who is expected to be difficult with effective mask ventilation
- •Children with severe neurological disease
- •Children with moyamoya disease
- •Children who is allergy to For dexmedetomidine or chloral hydrate
- •Preterm children, weight <2 kg
研究组 & 干预措施
Dexmedetomidine 1 ug/kg
1 ug/kg of intranasal dexmedetomidine
干预措施: intranasal dexmedetomidine (Drug)
Dexmedetomidine 2 ug/kg
2 ug/kg of intranasal dexmedetomidine
干预措施: intranasal dexmedetomidine (Drug)
结局指标
主要结局
Numbers of participants with successful rescue sedation
时间窗: 1 day
次要结局
- Numbers of participants with completement of ophthalmic examinations(1 day)
研究者
Haotian Lin
Ophthalmologist
Sun Yat-sen University