| CTRI Number |
CTRI/2025/08/093256 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in intubated children |
|
Scientific Title of Study
|
Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in mechanically ventilated children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Unnati Sharma |
| Designation |
Post graduate student in department of pediatrics, University college of medical sciences, Delhi |
| Affiliation |
University College of Medical Sciences and GTB hospital, Delhi |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden,
Delhi-110095
North East
DELHI
110095
India
North East
DELHI
110095
India |
| Phone |
9540212929 |
| Fax |
|
| Email |
unnatisinkona26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Batra |
| Designation |
Director Professor in department of pediatrics, University college of medical sciences, Delhi |
| Affiliation |
University College of Medical Sciences and GTB hospital, Delhi |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden,
Delhi-110095
North East
DELHI
110095
India
North East
DELHI
110095
India |
| Phone |
9958672759 |
| Fax |
|
| Email |
drprernabatra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Unnati Sharma |
| Designation |
Post graduate student in department of pediatrics, University college of medical sciences, Delhi |
| Affiliation |
University College of Medical Sciences and GTB hospital, Delhi |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden,
Delhi-110095
North East
North East
DELHI
110095
India |
| Phone |
9540212929 |
| Fax |
|
| Email |
unnatisinkona26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant by UCMS and GTB Hospital, Dilshad Garden, Delhi-110095, India |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
UCMS and GTB Hospital, Dilshad Garden, Delhi-110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Unnati Sharma |
UCMS and GTB Hospital |
Pediatric intensive care unit (PICU) and pediatric emergency, Second floor, MCH Building, Dilshad Garden, Delhi-110095
North East
DELHI |
9540212929
unnatisinkona26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z991||Dependence on respirator, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomidine infusion |
Subject will receive continuous intravenous dexmedetomidine infusion at dose of 0.25 mcg/kg/hr to maximum dose of 0.75 mcg/kg/hr for maximum duration of 48 hours |
| Comparator Agent |
Intravenous midazolam plus fentanyl infusion |
Subject will receive continuous intravenous midazolam at dose of 2 mcg/kg/min to maximum dose of 6 mcg/kg/min plus fentanyl infusion at dose of 1 mcg/kg/hr to maximum dose of 3 mcg/kg/hr for maximum duration of 48 hours |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children aged between 1 year to 12 year, admitted in PICU and requiring mechanical ventilation |
|
| ExclusionCriteria |
| Details |
1. History of known allergy or reaction to dexmedetomidine or midazolam or fentanyl
2. Patients with neuro-paralytic disorder
3. Patients already on sedation
4. Patients with hepatic involvement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of time spent in level -3 to -4 of RASS |
From enrollment to 48 hours of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to achieve -3 or -4 sedation level of RASS |
From enrollment to time taken to achieve -3 or -4 level of RASS |
| Number of additional boluses required |
From enrollment to 48 hours of study |
| Episodes of bradycardia, hypotension and any other adverse effect |
From enrollment to 48 hours of study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/08/2025 |
| 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="4"
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
|
This study has been designed to assess the efficacy of dexmedetomidine compared to the conventional midazolam plus fentanyl regimen for sedation in mechanically ventilated children. Adequate sedation and analgesia are essential in mechanically ventilated children to reduce agitation, ensure safety, and synchronize breathing with the ventilator. Midazolam plus fentanyl is widely used but associated with adverse events including bradycardia and hypotension. Dexmedetomidine, an alpha 2 adrenergic agonist with both sedative and analgesic properties and minimal respiratory depression, shows promise as an alternative. There is paucity of data on use of dexmedetomidine as first line sedative during mechanical ventilation in children. Few studies have shown the role of dexmedetomidine in sedation in reducing time duration of sedation and extubation duration and results have been promising. Therefore, through this study, we propose to evaluate efficacy of dexmedetomidine in children on mechanical ventilation admitted in pediatric intensive care unit as compared to midazolam plus fentanyl. |