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临床试验/CTRI/2024/12/077530
CTRI/2024/12/077530尚未招募不适用

Oral midazolam premedication in paediatric oncology patients undergoing day care procedures- Does it improve mask acceptance?

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
83
试验地点
1
主要终点
To improve the mask acceptance score by use of oral midazolam as pre medication

研究概览

简要总结

Pre medication is given routinely as a part of standard anaesthesia care in paediatric patients undergoing major surgical procedures.This practice is not followed in paediatric patients undergoing short duration procedures as the parents are allowed to accompany the child into the operation theatre (OT). Even with the parents around, children fear and resist the process of mask induction. Often these children are posted for minor procedures multiple times and repeated exposure to this fear of mask can remain in the memory of the children leading to long term complications like enuresis, night terrors and other psychological disorders.Therefore, premedication of children is important for smooth induction of anaesthesia and recovery.

Oralmidazolam is the most widely used and accepted method of premedicating children. For ease of parental separation, we routinely giveoral midazolam premedication to all children undergoing major surgical procedures. Unlike procedures in major operation theatres where parents are not allowed to accompany the child into the operation theatre, parents are allowed inside the procedure rooms for day care procedures.Hence, premedication was avoided in children coming for day care procedures. Also, in high volume centres there is insufficient time between two procedures to give premedication to the children. However, despite the presence of parents children cry excessively and do not easily accept the mask for induction of anaesthesia.

The purpose of this study is to see if giving oral midazolam, helps to improve the mask acceptance during anaesthesia for short procedures (bone marrow biopsy/aspiration, csf analysis, intrathecal methotrexate injection) without causing any delay in between two procedures or any delay in discharge from the recovery.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Age group-1 to 6years of either sex.
  • American society of anaesthesiology (ASA) 1, II & III 3)Informed consent by parents or guardians.

排除标准

  • Patients with ASA grade IV or more.
  • children with anticipated difficult airway 3)Allergy history to midazolam 4)Unwilling patients.
  • Patients who receive IV induction agents.

结局指标

主要结局

To improve the mask acceptance score by use of oral midazolam as pre medication

时间窗: Within 1 hour of intervention

次要结局

  • 1. Time of onset of sedation(2. Ease of separation from parents)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nayana Amin

Tata Memorial Centre

研究点 (1)

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