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CTRI Number  CTRI/2021/01/030771 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Dexmeditomedine versus Morphine for sedation in preterm babies 
Scientific Title of Study   Dexmeditomedine vs Morphine Infusion for pain relief in mechanically ventilated preterm neonates: A Randomized Control Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepti Thandaveshwara 
Designation  Assistant Professor 
Affiliation  JSS Medical College 
Address  Department of Pediatrics, JSS Hospital, MG Road, Mysuru, Karnataka
JSS Academy of Higher Education and Research Bannimantap Bangalore Mysore Road, Mysuru
Mysore
KARNATAKA
570004
India 
Phone  09845023309  
Fax    
Email  deeptiadarsh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Thandaveshwara 
Designation  Assistant Professor 
Affiliation  JSS Medical College 
Address  Department of Pediatrics, JSS Hospital, MG Road, Mysuru, Karnataka
JSS Academy of Higher Education and Research Bannimantap Bangalore Mysore Road, Mysuru
Mysore
KARNATAKA
570004
India 
Phone  09845023309  
Fax    
Email  deeptiadarsh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Thandaveshwara 
Designation  Assistant Professor 
Affiliation  JSS Medical College 
Address  Department of Pediatrics, JSS Hospital, MG Road, Mysuru, Karnataka
JSS Academy of Higher Education and Research Bannimantap Bangalore Mysore Road, Mysuru
Mysore
KARNATAKA
570004
India 
Phone  09845023309  
Fax    
Email  deeptiadarsh@gmail.com  
 
Source of Monetary or Material Support  
JSS Hospital,MG Road,Mysore 570004 
 
Primary Sponsor  
Name  JSS Medical College 
Address  Bannimantap, Mysore Bangalore Road, Mysore, Karnataka 
Type of Sponsor  Private 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 
Dr Deepti Thandaveshwara  Neonatal Intensive Care Unit  2nd floor,JSS Hospital, MG Road,Mysore570004
Mysore
KARNATAKA 
9845023309

deeptiadarsh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmeditomedine  Babies in this group will receive injection Dexmeditomedine stat dose 0.5 micrograms/kg followed by infusion of 0.2 mics/kg/hr. All babies are assessed for pain and sedation by N-PASS scoring system every two hours. If 2 consecutive scoring is 3, then the infusion is increased by 0.1 mics (max.0.7 mics/kg/hr) till two consecutive scoring is 3. If score persists 3 inspite of maximum dose of Dexmeditomedine then adjunct drug Midazolam is started. Drug will be completely weaned off over next 8 hours in both groups before extubation. In case if extubation becomes imperative due to agitation, then the drug will be stopped and the baby will be extubated  
Comparator Agent  Morphine   Babies in the control group will receive injection Morphine stat dose 100 micrograms/kg followed by infusion of 10 mics/kg/hr. All babies are assessed for pain and sedation by N-PASS scoring system every two hours. If 2 consecutive scoring is 3, then the infusion is increased by 2 mics (max.20 mics/kg/hr) till two consecutive scoring is 3. If score persists 3 inspite of maximum dose of morphine then adjunct drug, midazolam is started.Drug will be completely weaned off over next 8 hours in both groups before extubation. In case if extubation becomes imperative due to agitation, then the drug will be stopped and the baby will be extubated  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Preterm neonates between 28 and 36 weeks of gestation needing mechanical ventilation 
 
ExclusionCriteria 
Details  Term babies
Babies with congenital anomalies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to achieve pain relief in the first 24 hours of commencing mechanical ventilation and hemodynamic stability during the study period.   Pain to be assessed once in every 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic instability in terms of bradycardia or hypotension needing inotropes.  Within 24 hours 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 2 
Date of First Enrollment (India)   01/02/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Preterm neonates require care in the neonatal intensive care unit for various reasons. One of the common problems encountered in these neonates is respiratory distress syndrome where the management could be either using CPAP or mechanical ventilation. Newborn infants, including those born extremely preterm, can perceive pain. The entire duration when the neonate is on the ventilator could be a stressful experience for the neonate. Pain if unmanaged can have an immediate impact on hemodynamic and physiologic stability and altered stress hormone expression. There could also be long term effects on brain growth, development, cognition, and motor components. Hence alleviating pain is of prime importance. Various drugs have been used in intensive care units to reduce pain in neonates. Current neonatal drug regimens used to achieve pain relief generally consist of combinations of benzodiazepines and opioids like morphine, fentanyl, midazolam .  Though these drugs have proven efficacy as sedatives and analgesics, they are often accompanied by a spectrum of side effects that might prolong the duration of ventilation and hospitalization. There is always a search for newer sedatives and analgesics which have fewer adverse effects. Dexmedetomidine is one such drug that has been tried as it provides both sedation and analgesia when used alone, and has benzodiazepine and opioid‐sparing properties when used in combination with more conventional agents. The current study is being undertaken to know the efficacy of Dexmeditomedine versus morphine infusion in preterm ventilated neonates.

 
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