Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the efficacy of premedication on ramsey sedation score
研究概览
简要总结
The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.
详细描述
Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the pediatric patients undergoing strabismus surgery
- •the pediatric patients between 2-11 years old
- •ASA physical status I-II
- •the patients whose parents give permission for this study
排除标准
- •a known drud allergy or hypersensitive reaction to drugs used
- •mental retardation
- •cardiac arrhythmia or congenital cardiac disease
- •organ disfunction (liver , kidney)
- •nasal pathology
- •psychotropic treatment
研究组 & 干预措施
dexmedetomidine
intranasal 1mcg/kg
干预措施: Dexmedetomidine (Drug)
ketamine
intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
干预措施: Ketamine (Drug)
结局指标
主要结局
the efficacy of premedication on ramsey sedation score
时间窗: 30 min after premedication
after drug administration ramsey sedation scale is evaluate every 5 min.
次要结局
- the effects of premedication on oculocardiac reflex(during the surgery)
- mask acceptance scale(30 min after sedation)
- the parenteral separation anxiety scale(30 min after sedation)
研究者
müge yüce yıldırım
resident
TC Erciyes University