Comparison of oral midazolam with intranasal Dexmedetomidine premedication for children undergoing CT imaging: randomized, double blind and controlled study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- incidence of children requiring rescue sedation (IV ketamine)
研究概览
简要总结
Infants and children frequently require sedation to prevent motion artifacts during radiological imaging. We compared intranasal dexmedetomidine premedication (2.5mcg/kg) with oral midazolam 0.5 mg/kg for sedation in children undergoing CT imaging. Children were randomized to one of the two groups Group M received 0.5 mg/Kg midazolam and group D received 2.5 mc/Kg intranasal dexmedetomidine. After 20-30 minutes IV line was placed. The child was then transferred to CT table for imaging. Wilton score were observed and noted at that time. According to the level of sedation and scan duration, the child received 0.5 –1mg/Kg I.V ketamine to achieve a level of deep sedation. Any movement, motion artifact or repeat scans reported by radiologist were noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I or II children aged 1 – 5 years scheduled for CT imaging under sedation.
排除标准
- •Children with history of allergy to eutectic mixture of local anesthetic (EMLA) cream, midazolam severe dysfunction of central nervous system, malformation of cardiovascular system, children on chronic hepatic enzyme inducing drugs or mentally retarded children.
结局指标
主要结局
incidence of children requiring rescue sedation (IV ketamine)
时间窗: during CT Imaging
次要结局
- incidence of children crying at venipuncture, number of attempts at venipuncture, sedation and venipuncture scores, requirement of ketamine for CT, parental satisfaction, movements and motion artifacts during scan and requirement of repeat scan(at venepuncture and during CT imaging)