Comparison of Atomized Sublingual Dexmedetomidine and Oral Midazolam as Preanaesthetic Medication in Children: A Prospective, Double Blind, Randomised Control Trial
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
- Behaviour of the child on separation from parent (Modified Observer assessment of alertness and sedation scale- MOAA/S of 3 or 4)
研究概览
简要总结
Preoperative anxiety is commonly seen in children coming for surgery with an incidence of at least 60%. Relieving pre and postoperative anxiety is an important concern for the paediatric anaesthesiologist. Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist and possesses sedative, analgesic, perioperative sympatholytic, anaesthetic-sparing, and hemodynamic-stabilizing properties, but lacks respiratory depression, making it a useful and safe adjunct in diverse clinical applications. Midazolam, a γ-amino-butyric acid (GABA) receptor inhibitor, is the most commonly used sedative drug for premedication in children. Midazolam is a water-soluble benzodiazepine with rapid onset and short duration of action. It provides effective sedation, anxiolysis, and varying degrees of anterograde amnesia.
Sublingual route has an advantage of mucosal absorption directly into the systemic circulation with no first pass hepatic metabolism due to the rich blood supply of oral mucosa, is easy to administer, has rapid action, reliable predictable effect and the drug is not destroyed by the gastrointestinal enzymes.
A mucosal atomiser device (MAD) delivers medications via a fine spray over a broad surface area. Higher drug serum levels are achieved when a drug is given in its atomized form, due to a more extensive distribution of the medication across the mucosa and increased bioavailability of the drug. From the perspective of patient acceptance, administration of atomized spray has also been shown to produce significantly less aversive behaviour in young children, making it a practical option.
The aim of this study is to compare the ease of child-parent separation between sublingual atomized dexmedetomidine and sublingual atomized midazolam groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists Physical Status (ASA PS) 1 and 2, Weight 10 to 20 kg, Elective minor surgery under general anesthesia.
排除标准
- •American Society of Anesthesiologists Physical Status (ASA PS) 3 and 4, Weight < 10 kg or > 20 kg, Known allergy or hypersensitivity to dexmedetomidine, Parental/ Guardian refusal, Severe developmental delay or behavioural problems, Emergency cases, Cardiac arrhythmia or congenital heart disease, Surgeries more than 4 hour duration, Haemodynamic or respiratory instability, Children at risk for airway obstruction (obstructive sleep apnoea or a craniofacial syndrome), Any treatment with sedatives or anticonvulsants, Children who spit, vomited or refused sublingual administration of medication will also be excluded from the study.
结局指标
主要结局
Behaviour of the child on separation from parent (Modified Observer assessment of alertness and sedation scale- MOAA/S of 3 or 4)
时间窗: At 2 years
次要结局
- - Acceptability of the drug via sublingual route(- Mask acceptance (Mask acceptance score of 1 or 2))