跳至主要内容
临床试验/CTRI/2024/03/064170
CTRI/2024/03/064170已完成4 期

The effect of recorded mothers voice vs dexmedetomidine on emergence delirium in children undergoing adenotonsillectomy-A prospective randomized study

Sugganya N1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
1.Incidence and grading of emergence delirium

研究概览

简要总结

Emergence delirium in children is characterised by being in a dissociative state of consciousness with irritability, crying,moaning,kicking and thrashing.It can cause self injury to patients and has an incidence of 20-80%.A mothers voice has been shown to have a strong impact on both behavioural and neuronal responses in children.The goal of this research is to compare the effect of listening to a recorded mothers voice versus intravenous dexmedetomidine on the incidence and severity of emergence delirium in children after adenotonsillectomy surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • ASA PS I and II.

排除标准

  • ASA PS III and IV Presence of development delay Deafness or hearing impairment History of allergies to said drugs Absence of mothers.

结局指标

主要结局

1.Incidence and grading of emergence delirium

时间窗: 1. At the time of extubation and 15 minute interval upto 2 hours. | 2.at the time of extubation and 15 minute interval upto 2 hours.

2.Need for rescue medications

时间窗: 1. At the time of extubation and 15 minute interval upto 2 hours. | 2.at the time of extubation and 15 minute interval upto 2 hours.

次要结局

  • 1.Sedation score(2.Extubation time)

研究者

发起方
Sugganya N
申办方类型
Other [Self financing]

研究点 (1)

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