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CTRI Number  CTRI/2026/03/105197 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Dexmedetomidine and Fentanyl to provide comfort and pain relief in newborn babies on ventilator 
Scientific Title of Study   Dexmedetomidine versus Fentanyl for Sedation and Analgesia in Mechanically Ventilated Neonates A superiority parallel group open label 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  Sudhanshu Tiwari 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  NICU, Mother and Child Block, Division of Neonatology, Department of Paediatrics, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  7490919597  
Fax    
Email  drsudhanshuafmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anu Sachdeva 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room No 801, C wing, 8th Floor, Mother and Child Block, Division of Neonatology, Department of Paediatrics, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9891392188  
Fax    
Email  dranuthukral@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sudhanshu Tiwari 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  NICU, Mother and Child Block, Division of Neonatology, Department of Paediatrics, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  7490919597  
Fax    
Email  drsudhanshuafmc@gmail.com  
 
Source of Monetary or Material Support  
Division of Neonatology, Department of Pediatrics, Mother and Child Block, AIIMS New Delhi, South Delhi, New Delhi, India 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Division of Neonatology, Department of Pediatrics, Mother and Child Block, AIIMS New Delhi, South Delhi, New Delhi, India 110029 
Type of Sponsor  Research institution and hospital 
 
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 Anu Sachdeva  AIIMS, New Delhi  Room 801, C Wing, 8th Floor, Mother and Child Block, Division of Neonatology, Department of Paediatrics, AIIMS New Delhi
South
DELHI 		 9891392188

dranuthukral@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for PG Research (Clinical Science)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuous intravenous Dexmedetomidine infusion  All neonates more than equal to 26 weeks of gestation requiring sedation and analgesia while requiring mechanical ventilation due to any cause will be screened for enrolment after applying inclusion and exclusion criteria and approaching the parents for consent. If consented the resident on duty will pick up a sealed envelope with allocation to continuous intravenous dexmedetomidine infusion arm. Sedation and analgesia will be titrated using NPASS scores, with standardized monitoring for bradycardia, hypotension, respiratory depression, and withdrawal. Drug infusions will be tapered according to protocol based weaning criteria linked to ventilator weaning readiness and hemodynamic stability. 
Comparator Agent  Continuous intravenous Fentanyl infusion  All neonates more than equal to 26 weeks of gestation requiring sedation and analgesia while requiring mechanical ventilation due to any cause will be screened for enrolment after applying inclusion and exclusion criteria and approaching the parents for consent. If consented the resident on duty will pick up a sealed envelope with allocation to continuous intravenous fentanyl infusion arm. Sedation and analgesia will be titrated using NPASS scores, with standardized monitoring for bradycardia, hypotension, respiratory depression, and withdrawal. Drug infusion will be tapered according to protocol based weaning criteria linked to ventilator weaning readiness and hemodynamic stability. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates more than equal to 26 0/7 weeks of gestation
Post menstrual age less than equal to 44 weeks
On invasive mechanical ventilation and requiring sedation/analgesia (as decided by clinical team)
Age at enrolment
Index episode of ventilation till 44 weeks post menstrual age
Each neonate will be enrolled only once in the study and a repeat enrolment during subsequent ventilation episodes will not be undertaken.
 
 
ExclusionCriteria 
Details  Neonates with shock requiring inotropes
Neonates with diagnosed cardiac rhythm abnormalities
Major chromosomal or genetic anomalies or congenital Anomalies (incompatible with life)
Neonate who has received any opioid analgesic drug in last 72 hours
Known allergy to fentanyl or dexmedetomidine
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the total duration of sedation and analgesia among mechanically ventilated neonates between those receiving dexmedetomidine and those receiving fentanyl.  Total duration of sedation and analgesia will be measured from initiation of infusion until successful discontinuation with right censoring at death or at the maximal follow up of 28 days  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the cumulative dose of rescue sedatives or analgesics (Fentanyl) required in neonates  From institution to removal of ventilatory support  
To compare the duration of mechanical ventilation   From intubation till successful extubation 
To compare the total length of stay in neonatal intensive care unit   From point of randomization till discharge 
The incidence of adverse effects such as bradycardia (defined as HR less than 90 per min), hypotension (BP less than 5th centile as per gestational age appropriate threshold), oxygen desaturation (SpO2 less than 90 percent) and episodes of agitation   From institution till end of drug infusion 
To compare the incidence of withdrawal   When the drug tapering is started till 72 hours of stoppage of drug 
To compare the proportion of patients who achieve and maintain target sedation and analgesia; NPASS target of less than equal to 2 without more than equal to 1 episode of treatment failure or need for protocolized rescue within the total duration of drug infusion  From institution till end of drug infusion 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   10/03/2026 
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="9"
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   This study will compare dexmedetomidine and fentanyl for providing sedation and analgesia in neonates who require invasive mechanical ventilation. Neonates of gestational age 26 weeks or more who need continuous sedative or analgesic infusion will be enrolled after informed consent and randomized to receive either dexmedetomidine or fentanyl. Drug dosing, titration, rescue medication, and cessation will follow standardized protocols. Sedation and analgesia will be assessed using the N PASS score, and vital signs including heart rate, blood pressure, respiratory rate, and oxygen saturation will be monitored regularly. The primary outcome is the total duration of sedative or analgesic infusion, measured from initiation of drug infusion until its final discontinuation and will be analyzed as a time to event variable with censoring for death or maximum follow up of 28 days. Secondary outcomes include cumulative rescue fentanyl use, duration of mechanical ventilation, length of NICU stay, achievement and maintenance of target sedation without treatment failure, incidence of withdrawal assessed by modified Finnegan scoring, and adverse effects such as bradycardia, hypotension, desaturation, and agitation. The study will follow neonates through the index episode of ventilation until extubation, drug discontinuation, or 44 weeks postmenstrual age. 
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