Comparison Of Intranasal Dexmedetomidine Versus Intranasal Midazolam As Premedication In Paediatrcis Patients Posted For Day Care Surgery. A Randomised Double Blinded Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Parental separation anxiety scale
研究概览
简要总结
A comparison of intranasal Dexmedetomidine versus intranasal Midazolam as premedication in paediatrics patients posted for day care surgery , a randomized double-blinded study. Done using mucosal atomization device . The primary objective is to assess parenteral separation anxiety using the PSAS scale. A total of 102 patients aged between one and seven years were taken. One group will receive intranasal Dexmedetomidine 2mcg/kg drug diluted with 0.9% normal saline to the total volume of 2ml. The other group will get intranasal midazolam 0.2mg/kg diluted with 0.9 % normal saline to the total volume of 2 ml. Simple random sampling will be done. the primary outcome will assessed based on the parenteral separation anxiety scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •1 informed consent from parents or guardians 2 ASA grade I and II 3 patients undergoing paediatric day care surgery.
排除标准
- •1 patients having an upper respiratory tract infection 2 Emergency cases 3 known allergies to study drugs 4 significant organ dysfunction 5 congenital disorders 6 more than eighty five percentile of body mass index for age percentiles.
结局指标
主要结局
Parental separation anxiety scale
时间窗: 30 mins
次要结局
- Ramsay sedation scale(30 mins)
- Mask acceptance scale(30 mins)
- WATCHA scale of emergence delirium(30 mins)
- Hemodynamic parameters(Zero min,5,10,15,20,30, min and 1 hour)
- duration of hospital stay(24 hours)
研究者
SOHIL S
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh