A randomized prospective study comparing intranasal dexmedetomidine versus intranasal midazolam for sedation in pediatric patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the efficacy of intranasal dexmedetomidine and intranasal midazolam in pediatric patient for sedation.
研究概览
简要总结
Prior to any operative procedure, children are often susceptible to fear & anxiety of being separated from parents & entering the operating room environment. Premedication plays an important role in allowing a smooth separation of the child from the parent. One of the ways, an anaesthesiologist can deal with this challenge is to sedate the child beforehand. Children tolerate oral and nasal route better than intravenous route for needle fear. Preoperative anxiety during any procedure in children is a major concern, approximately 60% of pediatric patients suffer preoperative anxiety. Children may become overtly uncooperative at the time of separation from parents.
Nasal premedication with midazolam and dexmedetomidine has been studied as alternatives to oral premedication and injectables with comparable results. Intranasal route is a non-invasive route well tolerated by the pediatric patient . Bioavailability is highly primarily due to rich vasculature in the nasal mucosa. Onset of action is quicker than other systemic routes. Drugs administered via the nasal route are rapidly absorbed into the systemic circulation because they do not pass through portal circulation.
Dexmedetomidine is a newer alpha 2 agonist with mopre selective alpha 2 : alpha 1 adrenoreceptor activity with a short half life. Since this drug has a neutral pH, it is virtually painless when given given intanasally and it is also tasteless and odourless. Recently, it has been recommended for procedural sedation in children. In addition to its sedative property, dexmedetomidine exerts analgesics and antiemetic effects. In comparison with other ana;lgesics and sedative agents, dexmedetomidine has minimal effects on respiration.
Midazolam is one of the most commonly used sedative premedication in pediatric anaesthesia. It is employed in a variety of surgical and non surgical procedures. Midazolam is water soluble benzodiazepine that works by inhibiting the GABA receptor. It has sedative and anxiolytic properties, which makes easier to perform any procedure. As midazolam has high hepatic clearance , avoidance of first pass metabolism offers greater systemic bioavailabilty. The beneficial effect of modazolam includes rapid sedation, anxiolytic and reduction of post operative nausea and vomiting. However, the major drawback is that atleast 50% children cry on administration because it transiently irritates nasal passage.
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 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1 ASA CLASS I & II 2 Age from 1-12yrs.
- •3 Patients of either sex.
排除标准
- •1 Children with an allergy to the study drug.
- •2 Children with organ dysfunction.
- •Refusal by the parents.
结局指标
主要结局
To compare the efficacy of intranasal dexmedetomidine and intranasal midazolam in pediatric patient for sedation.
时间窗: 40mins
次要结局
- 1 To compare hemodynamic changes in both the groups.(2 To compare side effects in both the groups, if any.)
研究者
DR NEETU YADAV
Subharti medical college and hospital
