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临床试验/CTRI/2022/11/047095
CTRI/2022/11/047095招募中不适用

Comparison of popsicles of oral midazolam, ondansetron, Ketamine and Atropine (MOKA) vs midazolam, Ondansetron and Atropine (MOA) vs Ketamine, Ondansetron and Atropine (KOA) as oral premedication for elective pediatric surgeries

Saveetha Medical College Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年1月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
1
主要终点
To compare the separation anxiety in pediatric patients between the three groups MOKA (Midazolam+Ondansetron+Ketamine+Atropine), MOA (Midazolam+Ondansetron, Atropine), KOA (Ketamine+ Ondansetron+Atropine)

研究概览

简要总结

Introduction: Premedication is widely used in pediatric anesthesia for sedation and anxiolysis. The fear of surgery and anxiety will be present in children and their parents. An ideal premedication should relieve anxiety, facilitate parenteral separation, acceptance of IV cannula and face mask. Its Incidence are higher in pre-school children. Most anesthesiologists use either presence of parent or sedative premedication during induction. Separation from parents and induction of anesthesia are the vital stress factors for children in the perioperative period. A good premedication in pediatric age group should be easy to use, should have rapid onset and short duration of action with less side effects.

**Aim:**To investigate whether combination of midazolam and ketamine in reduced dose as popsicles has the advantages of improved sedation with faster recovery and fewer adverse effects compared to single agents.

Hypothesis: Combining midazolam and ketamine in reduced dose as ice cubes will provide better sedation and parenteral separation in pediatric cases when compared to giving separately in regular dose.

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
1.50 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Elective surgeries -Weighing between 10 kgs- 40 kgs -Procedures lasting more than 30 min -ASA I or II patients.

排除标准

  • ASA III or higher, congenital heart defects ,hypo or hyperthyroidism or any other endocrinal disturbances, severe CNS dysfunction, severe liver and renal disease, risk of aspiration, severe systemic illness, Respiratory tract infection (URI/LRTI) -Emergency cases.

结局指标

主要结局

To compare the separation anxiety in pediatric patients between the three groups MOKA (Midazolam+Ondansetron+Ketamine+Atropine), MOA (Midazolam+Ondansetron, Atropine), KOA (Ketamine+ Ondansetron+Atropine)

时间窗: -To assess the parental separation at 10min, 20min, 30min after administration of popsicle | This is done for all the three groups.

次要结局

  • -To compare the Sedation score between the three groups.(-To compare the ease of venous cannulation between the three groups.)

研究者

发起方
Saveetha Medical College Hospital
申办方类型
Private medical college

研究点 (1)

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