study of effect of dexmedetomidine nebulization on parental separation and mask acceptance in paediatric patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- parental separation
研究概览
简要总结
Preoperativeanxiety is seen in 50%-70% of the paediatric patients posted for surgery. Fearof parent separation, fear of strange hospital environment and painfulprocedures contribute to preoperative anxiety.1Children with highpreoperative anxiety have high incidence of postoperative pain, emergencedelirium, delayed discharge and maladaptive and behavioural changes that canlast for weeks in the postoperative period.2
Variouspharmacological and non-pharmacological methods are in practice with variablesuccess rate. Drugs, such as midazolam and ketamine, have been tried forthis via oral, nasal and parenteralroutes, but each one has its limitations.3
Inhalation of nebulised drug is an easyalternative for preoperative sedation in children as it avoids needle puncturenecessary for intravenous (IV) or intramuscular (IM) route. Dexmedetomidine,which is a selective alpha-2 agonist with central sedative and anxiolyticproperties,4 has been tried for preoperative anxiolysis in childrenvia nasal and inhalational routes.5 Previous study has suggestedthat nebulised dexmedetomidine can provide a clinically relevant, non-invasivealternative to the invasive IV or IM route of administration.6Thosestudies have used dexmedetomidine in the doses of 2 μg kg−1 and found that itwas effective in achieving calm parental separation in approximately 60%-70% ofchildren.7,8Dexmedetomidine in a dose of 3 µg kg−1 via parenteralroute has produced satisfactory procedural sedation without any haemodynamicadverse events.9,10
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •Inclusion Criteria: 1)Patients giving informed written consent.
- •Patients scheduled for elective surgery under general anaesthesia with endotracheal intubation.
- •Patients age between 1 to 10 years 4)Patients belonging to ASA I, II.
排除标准
- •Exclusion Criteria: 1)Patients who refused to give informed written consent.
- •Patients known to have allergy or hypersensitivity to dexmedetomidine 3)Any patient with nasal ulcers, polyps, nasal septum deviation 4)Patients with previous history of heart diseases 5)Patients with heart rate of <70 beats per minute 6)A second- or third-degree atrioventricular block 7)Patients with Asthma 8)Patients with organ dysfunction 9)Patients with mental illness.
结局指标
主要结局
parental separation
时间窗: Before shifting to operation theatre
mask acceptance
时间窗: Before shifting to operation theatre
次要结局
- mask acceptance(30mins)
