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
|
|
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. |