Comparing the effects of Midazolam and smartphone in reducing the uncomfortable,tense unpleasant mood before surgery in children

Not yet recruiting

Conditions: Factors influencing health status and contact with health services,

Registration Number: CTRI/2019/11/022119

Lead Sponsor: MS Ramaiah Medical College and Hospitals

Brief Summary: 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 Childrenâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of intravenous midazolam with smartphone distraction technique on the change of level of anxiety from baseline	Baseline,10 minutes after intervention,During parental separation,During the introduction of mask during Induction

Secondary Outcome Measures

Name	Time	Method
To compare the effect of intravenous midazolam with smartphone distraction technique on postoperative emergence delirium	At 15th and 30th minute post extubation

Trial Locations

Locations (1): M.S. Ramaiah Medical College and Hospitals
🇮🇳
Bangalore, KARNATAKA, India
M.S. Ramaiah Medical College and Hospitals
🇮🇳Bangalore, KARNATAKA, India
Dr Bindu TV
Principal investigator
8379939954
bindutvshyla@gmail.com