跳至主要内容
临床试验/CTRI/2019/11/022119
CTRI/2019/11/022119尚未招募不适用

Preoperative Anxiolysis In Children-A Comparative Study Of Effect Of Midazolam Versus Smartphone Application

MS Ramaiah Medical College and Hospitals1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
130
试验地点
1
主要终点
To compare the effect of intravenous midazolam with smartphone distraction technique on the change of level of anxiety from baseline

研究概览

简要总结

SurgeryAnd Anesthesia Can Trigger A Great Emotional Stress In Both Parents AndChildren. Change Of Environment (Operating Room), Parting From Parents,Anesthesia Induction Creates Extreme Anxiety In Children.This AnxietyMay Cause Considerable Adverse Outcome Such As Augmented PostoperativeAnalgesic Requirements, Postoperative Delirium, Maladaptive Behavior In TheImmediate Postoperative Period And May Persist As Post-Traumatic StressDisorder.Thus, Strategies To Prevent Or Reduce Anxiety Is Of AtMost Importance For Minimizing Adverse Impact In The Immediate PostoperativePeriod And Also Of The Psychological Milieu Of The Child In Future. Numerous StrategiesHave Been Analyzed Which Includes Pharmacological Methods, NonpharmacologicalMethods And Psychological Training.

PharmacologicalAgents Like Midazolam, Clonidine, Ketamine, Fentanyl And Other Agents Have BeenUsed But They May Be Associated With Undesirable Side Effects Such AsParadoxical Reactions, Prolonged Sedation And Adverse Behavioral Changes. However, Midazolam Is Established As The GoldStandard Method Of Preoperative Anxiolysis Against Which Other PremedicationStrategies Are Compared. Nonetheless Midazolam Has Potential For Prolonged EffectAnd Paradoxical Reactions Like A Restless And Agitated Child.NonpharmacologicalTechniques Include Parental Presence And Distraction Technique. Distraction IsA Nonpharmacological And Effective Technique That Directs Children’s AttentionAway From Anxiogenic Stimuli. There Is A Multitude Of Techniques AndTechnologies Associated With Distraction. Behavioral Interventions Like Use OfVideo Games And Comprehensive Family Centered Preoperative BehaviouralPreparation Program Significantly Benefitted Children In Terms Of ReducedAnxiety, Increased Compliance, Reduced Emergence Delirium And Reduced AnalgesicRequirements.Hence, We Have Designed The Current Study To CompareThe Impact Of Oral Midazolam And Smartphone Application On Preoperative AnxietyAnd Postoperative Emergence Delirium In Children.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • •1.American society of anesthesiologists (ASA) physical status 1 and 2 2.Age between 3-10 years.

排除标准

  • •1.Children with documented preoperative behavioural disturbances and psychiatric disorders 2.Use of psychoactive medication 3.History of developmental delay 4.Previous history of multiple surgery.

结局指标

主要结局

To compare the effect of intravenous midazolam with smartphone distraction technique on the change of level of anxiety from baseline

时间窗: Baseline,10 minutes after intervention,During parental separation,During the introduction of mask during Induction

次要结局

  • To compare the effect of intravenous midazolam with smartphone distraction technique on postoperative emergence delirium(At 15th and 30th minute post extubation)

研究者

发起方
MS Ramaiah Medical College and Hospitals
申办方类型
Private medical college

研究点 (1)

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