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CTRI Number  CTRI/2024/11/076689 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dexmedetomidine versus Midazolam for sedation in Pediatric Intensive Care Unit 
Scientific Title of Study   Efficacy of Dexmedetomidine compared to Midazolam for sedation in mechanically ventilated patients in Pediatric Intensive Care Unit- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Narayanan P 
Designation  Professor, Department of Pediatrics 
Affiliation  Professor, Pediatrics 
Address  Women and children Hospital, Jawaharlal Institute of Post Graduate Medical Education and Research

Pondicherry
PONDICHERRY
605006
India 
Phone  9443458850  
Fax    
Email  narayanan.p@jipmer.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Bisman Singh 
Designation  Senior Resident 
Affiliation  Senior Resident, Pediatrics 
Address  Women and children Hospital, Jawaharlal Institute of Postgraduate Medical Education and Research

Pondicherry
PONDICHERRY
605006
India 
Phone  9643027236  
Fax    
Email  bismansingh3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Narayanan P 
Designation  Professor 
Affiliation  Professor, Pediatrics 
Address  Women and children Hospital, Jawaharlal Institute of Postgraduate Medical Education and Research

Pondicherry
PONDICHERRY
605006
India 
Phone  9443458850  
Fax    
Email  narayanan.p@jipmer.edu.in  
 
Source of Monetary or Material Support  
Intramural Research Funds, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantari Nagar, Puducherry, 605006 India 
 
Primary Sponsor  
Name  Intramural research funds JIPMER 
Address  Jawaharlal Institute of Post Graduate Medical Education and Research, Dhanvantari Nagar, Puducherry, 605005 India 
Type of Sponsor  Government medical college 
 
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 
Narayanan P  Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry  2nd floor, Pediatric Intensive Care Unit, Women and Childrens Hospital
Pondicherry
PONDICHERRY 		 9443458850

narayanan.p@jipmer.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Interventional studies, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J962||Acute and chronic respiratory failure, (2) ICD-10 Condition: J188||Other pneumonia, unspecified organism, (3) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine infusion as primary sedative agent, to be titrated from 0.3 to 1.5 mcg/kg/hour, for a period of 120 hours, or till extubation, or till death; whichever is earlier 
Comparator Agent  Midazolam  Midazolam infusion as primary sedative agent, to be titrated from 1 to 5 mcg/kg/min, for a period of 120 hours, or till extubation, or till death; whichever is earlier. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Mechanically ventilated children in PICU 
 
ExclusionCriteria 
Details  Children with raised intracranial pressure, HIE sequelae, refractory shock, bradycardia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of sedation  5 days 
 
Secondary Outcome  
Outcome  TimePoints 
Delirium, Bolus doses of sedoanalgesia, iatrogenic withdrawal syndrome, adverse effects  5 days 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   Phase 3 
Date of First Enrollment (India)   18/11/2024 
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 Yet Recruiting 
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   We wish to test the efficacy of dexmedetomidine vs midazolam infusions for sedation of mechanically ventilated children in PICU, JIPMER. All children who meet inclusion criteria, after consent, will be started on either dexmedetomidine or midazolam infusion for sedation, and infusions will be prepared in such a way that dosing range will be 0.3-1.5 mcg/kg/hour for dexmedetomidine, and 1-5 mcg/kg/min for midazolam. Infusions will be prepared in such a way that this will correspond to 1-5 ml/hour rate for both drugs. Investigator, participants and outcome assessors will be blinded. Efficacy of sedation will be assessed using sedation scores every 6 hourly, and assessing the proportion of measurements, out of total measurements, when child was in adequate sedation. Means of the proportion between the two groups will be compared.  
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