“Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in pediatric undergoing surgical procedure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the degree of sedation provided by the administration of intranasal atomized dexmedetomidine and ketamine in both group.
研究概览
简要总结
Patients were randomised into two groups using random allocation software. Patients assigned to Group I received intranasal atomised dexmedetomidine 2.5mg/kg , 30 min before induction. Patients in Group II received intranasal atomised ketamine 5mg/kg 30 min before induction.
Both the study drugs were diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume was added to account for the dead space of the atomiser.
A detailed pre-anaesthetic evaluation was done and adequate fasting as per standard guidelines was ensured.
The calculated dose of the study drugs was administered using a 2 ml syringe and the mucosal atomisation device.
We administered half of the dose in one nostril and the other half in the other nostril in an upward and outward direction with the child in the supine position.
Sedation was assessed at 10, 20 and 30 min in both groups using the UMSS which is a simple, valid and reliable tool that facilitates rapid assessment and documentation of depth of sedation in children and a score of 2 was considered satisfactory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent,ASA 1and 2 patients,Age between 1-10years,Normal coagulation status.
排除标准
- •Not given written informed consent,ASA status 3 and 4 ,Abnormal coagulation,Hemodynamically unstable ,Hematological,cardiovascular disorder ,allergy or contraindication of study drugs,history of seizure,upper respiratory tract infection,Arnold chiari malformation,Active liver disease,Difficult airway,Intellectual disabiltiy.
结局指标
主要结局
To compare the degree of sedation provided by the administration of intranasal atomized dexmedetomidine and ketamine in both group.
时间窗: 3 months
次要结局
- To compare the ease of parental separation and venous cannulation in both groups along with the degree of successful mask acceptance , perioperative vital parameter, along with incidence of emergency agitation.(3 months)
研究者
Dr Shubam Achari
Maharani laxmi bai medical college jhansi