Comparison of midazolam, ketamine and dexmedetomidine as premedications for radiological imaging in children under 10 years of age
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children.
研究概览
简要总结
Paediatric patients are a population with a high level of anxiety. The prevention of perioperative stress in a frightened child is important to render the child calm and cooperative for smoother induction. Intranasal premedication is easy and safe, and the drug is rapidly absorbed into the systemic circulation, ensuring early onset of sedation in children and good effectiveness.
Pain, fear, anxiety, and anger are the main emotional components to be dealt by a pedodontist while treating a child. It is generally agreed that most fearful and uncooperative children should be managed with behavioral (nonpharmacologic) management procedures such as tell-show-do, positive reinforcement, controlled expectations, modeling, and suggestion.The primary aim of pharmacological sedation in paediatrics is to transform the patient’s behavior to a level that allows employing behavior management techniques. Intranasal administration of the drugs is well tolerated by children, effective and fast acting as this site is highly vascularized and very permeable for drug administration, ensuring rapid absorption into systemic circulation.
This proposal may suggest that sedative agents such as midazolam, ketamine, dexmedetomidine evaluated in this study in a paediatric population can be used safely and effectively in uncooperative pediatric patients for producing conscious sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Children under 18 years of age requiring sedative agents for investigation purposes.
排除标准
- •Patients requiring mechanical ventilation and intravenous inotropic support and those with cyanotic CHD, second- and third-degree heart.
- •Children with muscular dystrophies, multiple congenital anomalies, hepatic or renal dysfunction, and allergy to any of the used drugs were excluded.
结局指标
主要结局
To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children.
时间窗: To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children under 10 years of age , for a period of 24 hours post sedations
次要结局
- TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION(TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION AND ADVERSE EVENTS THAT OCCUR WITHIN 24 HOURS AFTER SEDATION)
研究者
REXINA DARTHY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
