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CTRI Number  CTRI/2019/11/022119 [Registered on: 22/11/2019] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effects of Midazolam and smartphone in reducing the uncomfortable,tense unpleasant mood before surgery in children 
Scientific Title of Study   Preoperative Anxiolysis In Children-A Comparative Study Of Effect Of Midazolam Versus Smartphone Application 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bindu TV 
Designation  Post Graduate 
Affiliation  M.S. Ramaiah Medical College 
Address  Department Of Anesthesiology M.S. Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  8379939954  
Fax    
Email  bindutvshyla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetha C R 
Designation  Professor  
Affiliation  M.S. Ramaiah Medical College  
Address  Department Of Anesthesiology M.S. Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu TV 
Designation  Post Graduate 
Affiliation  M.S. Ramaiah Medical College 
Address  Department Of Anesthesiology M.S. Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  8379939954  
Fax    
Email  bindutvshyla@gmail.com  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College and Hospitals,M S R Nagar,Mathikere,Bengaluru,Karnataka-560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College and Hospitals 
Address  M.S. Ramaiah Medical College Bangalore-560054  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Bindu TV  Postgraduate,Department Of Anesthesia, M.S. Ramaiah Medical College, Bangalore  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bindu TV  M.S. Ramaiah Medical College and Hospitals  Post Graduate, Department Of Anesthesia, M.S. Ramaiah Medical College, Bangalore
Bangalore
KARNATAKA 
8379939954

bindutvshyla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee M S Ramaiah Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  midazolam  midazolam 0.1mg/kg given intravenously once in the preoperative period 15 minutes before shifting the patient inside the operation theater 
Comparator Agent  smartphone   children are given the smartphone application of their choice to play preoperatively till induction 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.American society of anesthesiologists (ASA) physical status 1 and 2
2.Age between 3-10 years
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
To compare the effect of intravenous midazolam with smartphone distraction technique on postoperative emergence delirium   At 15th and 30th minute post extubation 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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

Pharmacological Agents Like Midazolam, Clonidine, Ketamine, Fentanyl And Other Agents Have Been Used But They May Be Associated With Undesirable Side Effects Such As Paradoxical Reactions, Prolonged Sedation And Adverse Behavioral Changes. However, Midazolam Is Established As The Gold Standard Method Of Preoperative Anxiolysis Against Which Other Premedication Strategies Are Compared. Nonetheless Midazolam Has Potential For Prolonged Effect And Paradoxical Reactions Like A Restless And Agitated Child.Nonpharmacological Techniques Include Parental Presence And Distraction Technique. Distraction Is A Nonpharmacological And Effective Technique That Directs Children’s Attention Away From Anxiogenic Stimuli. There Is A Multitude Of Techniques And Technologies Associated With Distraction. Behavioral Interventions Like Use Of Video Games And Comprehensive Family Centered Preoperative Behavioural Preparation Program Significantly Benefitted Children In Terms Of Reduced Anxiety, Increased Compliance, Reduced Emergence Delirium And Reduced Analgesic Requirements.Hence, We Have Designed The Current Study To Compare The Impact Of Oral Midazolam And Smartphone Application On Preoperative Anxiety And Postoperative Emergence Delirium In Children.


 
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