COMPARATIVE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TO EVALUATE AND COMPARE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL(ROUTE) DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALE TAKING ONE BASELINE THEN AFTER ,30MIN,45MIN,JUST AFTER TAKING IN OPERATION THEATRE
研究概览
简要总结
Preoperative anxiety in children is a major concern to the pediatric anesthesiologist. Children may become overtly uncooperative at the time of seperation from parents , venipuncture, or mask application.
Preinduction techniques ,aimed at reducing preoperative anxiety.
For sedative medications ketamine ,midazolam, fentanyl have been used with variable results. Dexmedetomedine is a highly selective alpha-2 adrenoceptor agonist that provides sedation, anxiolysis and analgesic effects without causing respiratory depression.
In children it is a difficult and even traumatic to obtain iv acess and lack of cooperation like swallowing for oral route makes the transmucosal route a more preferred one.
We plan to undertake this to objectively assess and compare the efficacy of these three doses of dexmedetomedine as premedications by these objective validated scoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •AGE 1-6 YRS ASA GRADE ONE AND TWO PATIENT UNDERGOING GENERAL ANESTHESIA.
排除标准
- •KNOWN ALLERGY OR HYPER SENSITIVITY TO DEXMEDETOMEDINE.
- •ABERRANT NASAL ANATOMY.
- •ACUTE OR CHRONIC NASAL TRAUMA THAT MAY PRECLUDE ADEQUATE INTRANASAL DELIVERY OF DRUG.
- •ANTICIPATED DIFFICULT AIRWAY.
- •LIVER DYSFUNCTION.
- •CARDIAC ARRHYTHMIAS, CONGENITAL HEART DISEASE ,MENTL RETARDATION.
结局指标
主要结局
TO EVALUATE AND COMPARE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL(ROUTE) DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALE TAKING ONE BASELINE THEN AFTER ,30MIN,45MIN,JUST AFTER TAKING IN OPERATION THEATRE
时间窗: TO EVALUATE AND COMPARE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALEEFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL(ROUTE) DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALE TAKING ONE AT BASELINE THEN AFTER ,30MIN,45MIN,JUST AFTER TAKING IN OPERATION THEATRE
次要结局
- 1-INDUCTION COMPLIANCE USING INDUCTION COMPLIANCE CHECKLIST.(2-HEMODYNAMIC RESPONSES TO DEFINITIVE AIRWAY INSERTION)