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临床试验/CTRI/2018/03/012863
CTRI/2018/03/012863已完成4 期

comparison between premedication with intravenous midazolam and use of behavioral intervention to reduce preoperative anxiety in children

msramaiah medical college and hospitals1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年1月7日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
To evaluate the efficacy of behavioral intervention program by giving toys and the effects with premedication with intravenous midazolam reduce anxiety in children preoperatively

研究概览

简要总结

Allchildren fulfilling the inclusion criteria will be visited on the preoperative day for pre anaesthetic evaluationby a consultant or resident who will anaesthetize the child next day. Childrenin the behavioral intervention group will be given a basket of toys. They willbe allowed to select toy of their choice. They will also be given circuits andmasks for familiarization. They will be thought how to breathe through thecircuit. Children in the midazolam group will not be given any toys after preanesthetic evaluation. Intravenous line will be placed for all children in thewards.

Onthe day of surgery after the children are shifted to pre anaesthetic areamodified yale pre operative anxiety scale (mYPAS) Appendix 1 will be recordedin both the groups. Children in behavioral intervention group will be giventoys and allowed to play with them. Children in the midazolam group willreceive intravenous midazolam 0.1mg/kg. After 10 mins mYPAS score will berecorded in both the groups and the children will be shifted to operationtheater. The last mYPAS score will be recorded just before induction ofanaesthesia.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
3.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • children between 3 to 9 years of ASA 1 and 2 posted for elective minor surgeries.

排除标准

  • children below 3 years and above 9 years.

结局指标

主要结局

To evaluate the efficacy of behavioral intervention program by giving toys and the effects with premedication with intravenous midazolam reduce anxiety in children preoperatively

时间窗: 10 minutes and 20 minutes after intervention

次要结局

  • postoperative sedation(10 minutes after surgery)

研究者

发起方
msramaiah medical college and hospitals
申办方类型
Private medical college

研究点 (1)

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