跳至主要内容
临床试验/CTRI/2022/04/042132
CTRI/2022/04/042132尚未招募不适用

study of effect of dexmedetomidine nebulization on parental separation and mask acceptance in paediatric patients

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年4月26日最近更新:

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)

研究者

发起方
Bangalore Medical College and Research Institute
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验