Comparison of the efficacy of Intranasal Atomised Dexmedetomidine versus Intranasal Atomised ketamine as a premedicant for anxiolysis and sedation in paediatric population aged 1-10 years undergoing spinal dysraphism surgery - a randomised double blinded controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ankur Luthra
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of sedation between intranasal atomised dexmedetomidine versus intranasal atomised ketamine in pediatric population aged 1-10yr undergoing spinal dysraphism surgery by using University of Michigan Sedation Scale (UMSS).
研究概览
简要总结
The Perioperative period can be veery traumatic time for young children undergoing any form of surgery. Anaesthesiologists strive to m minimise distress for children in the operating room and provide smooth induction of anaesthesia. Various premedications have been used to allay anxiety and facilitate smooth separation of children from their parents. Intranasal administration is easy and safe and reduces discomfort. Drugs like dexmedetomidine, ketamine, midazolam and fentanyl have been tried for sedation and anxiolysis. Atomisation of drug refers to making an aerosol, which gets better absorbed through the nasal mucosa and provides quite effective sedation. Since, there is discrepancy in the results of various studies on the superiority of one drug over the other via intranasal route by drops and there is no study comparing effectiveness of intranasal atomised dexmedetomidine versus ketamine for premedication in children, we hypothesised that intranasal atomised dexmedetomidine is equally effective to intranasal atomised ketamine as premedicant for anxiolytics and sedation in children of 1-10 years undergoing spinal dysraphism surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •64 ASA I and II children aged between 1-10years scheduled for spinal dysraphism surgery will be enrolled in this study.
排除标准
- •Refusal of consent Known allergy to dexmedetomidine or ketamine ASA III or IV Children with cardiac anomalies Children with seizures Children with upper respiratory tract infection Children with liver disease Children with mental retardation Difficult cannulation (three or more attempts).
结局指标
主要结局
To compare the effectiveness of sedation between intranasal atomised dexmedetomidine versus intranasal atomised ketamine in pediatric population aged 1-10yr undergoing spinal dysraphism surgery by using University of Michigan Sedation Scale (UMSS).
时间窗: At 30 minutes post drug administration via intranasal route.
次要结局
- To compare the response to parental separation assessed by Parental Separation Anxiety Score (PSAS)(30 min after drug administration)
- To compare the time for post operative discharge from PACU by Modified Aldrete Scoring(At the end of PACU stay)
- To compare incidence of Emergence agitation assessed by using WATCHA Scale(At the end of surgery)
- To compare the successful rate of venous canulation assessed by Groningen Distress Rating Score(30 min after drug administration)
- To compare mask acceptance assessed by Mask Acceptance Scale(30 min after drug administration)
- To compare the hemodynamic changes (HR, MAP, SpO2) intraoperatively(35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 65 min, 70 min, 75 min, 80 min, 85 min and 90 min after drug administration)