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CTRI Number  CTRI/2025/07/090838 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing Midazolam, Ketamine, and Dexmedetomidine as Sedation Options for Children Undergoing Radiology Scans 
Scientific Title of Study   Comparison of midazolam, ketamine and dexmedetomidine as premedications for radiological imaging in children under 10 years of age  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  REXINA DARTHY 
Designation  JUNIOR RESIDENT 
Affiliation  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Address  A BLOCK DEPARTMENT OF PAEDIATRCIS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
CHETTINAD ACADEMY AND RESEARCH EDUCATION
Chennai
TAMIL NADU
603103
India 
Phone  9043593599  
Fax    
Email  rexinadarthyjs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR JAISHREE 
Designation  HEAD OF DEPARTMENT 
Affiliation  CHETTINA HOSPITAL AND RESEARCH INSTITUTE 
Address  A BLOCK DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
CHETTINAD ACADEMY AND RESEARCH EDUCATION
Chennai
TAMIL NADU
603103
India 
Phone  9444362134  
Fax    
Email  vsdvnjshr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR JAISHREE 
Designation  HEAD OF DEPARTMENT 
Affiliation  CHETTINA HOSPITAL AND RESEARCH INSTITUTE 
Address  A BLOCK DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
CHETTINAD ACADEMY AND RESEARCH EDUCATION
Chennai
TAMIL NADU
603103
India 
Phone  9444362134  
Fax    
Email  vsdvnjshr@gmail.com  
 
Source of Monetary or Material Support  
A BLOCK DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE TAMIL NADU - 603103 INIDA  
 
Primary Sponsor  
Name  DR REXINA DARTHY 
Address  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR REXINA DARTHY  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE  A BLOCK DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE CHETTINAD ACADEMY AND RESEARCH EDUCATION TAMIL NADU - 603103
Chennai
TAMIL NADU 
9043593599

rexinadarthyjs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  sedative drugs such as midazolam, ketamine, dexmedetomidine   Children undergoing radiological investigations are given intravenous sedative agents to prevent anxiety during imaging  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children under 18 years of age requiring sedative agents for investigation purposes 
 
ExclusionCriteria 
Details  Patients requiring mechanical ventilation and intravenous inotropic support and those with cyanotic CHD, second- and third-degree heart. Children with muscular dystrophies, multiple congenital anomalies, hepatic or renal dysfunction, and allergy to any of the used drugs were excluded. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children.  To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children under 10 years of age , for a period of 24 hours post sedations 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION  TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION AND ADVERSE EVENTS THAT OCCUR WITHIN 24 HOURS AFTER SEDATION 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   23/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/07/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Paediatric patients are a population with a high level of anxiety. The prevention of perioperative stress in a frightened child is important to render the child calm and cooperative for smoother induction. Intranasal premedication is easy and safe, and the drug is rapidly absorbed into the systemic circulation, ensuring early onset of sedation in children and good effectiveness.

Pain, fear, anxiety, and anger are the main emotional components to be dealt by a pedodontist while treating a child. It is generally agreed that most fearful and uncooperative children should be managed with behavioral (nonpharmacologic) management procedures such as tell-show-do, positive reinforcement, controlled expectations, modeling, and suggestion.The primary aim of pharmacological sedation in paediatrics is to transform the patient’s behavior to a level that allows employing behavior management techniques. Intranasal administration of the drugs is well tolerated by children, effective and fast acting as this site is highly vascularized and very permeable for drug administration, ensuring rapid absorption into systemic circulation. 

This proposal may suggest that sedative agents such as midazolam, ketamine, dexmedetomidine evaluated in this study in a paediatric population can be used safely and effectively in uncooperative pediatric patients for producing conscious sedation.

 
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