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CTRI Number  CTRI/2021/01/030822 [Registered on: 28/01/2021] Trial Registered Prospectively
Last Modified On: 16/07/2021
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 Vs Morphine infusion in term babies 
Scientific Title of Study   Dexmeditomedine Vs Morphine infusion for sedation in mechanically ventilated Term Neonates  
Trial Acronym  Dexmeditomedine Vs Morphine 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSushma Krishnegowda 
Designation  Assistant Professor 
Affiliation  JSS Medical College, JSS Academy of higher education and Research 
Address  Department of Pediatrics JSS Hospital Agrahara, Mysuru
Bannimantap, mysore
Mysore
KARNATAKA
570004
India 
Phone  9742299896  
Fax    
Email  drsushmasri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSushma Krishnegowda 
Designation  Assistant Professor 
Affiliation  JSS Medical College, JSS Academy of higher education and Research 
Address  Department of Pediatrics JSS Hospital Agrahara, Mysuru
Bannimantap, mysore
Mysore
KARNATAKA
570004
India 
Phone  9742299896  
Fax    
Email  drsushmasri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSushma Krishnegowda 
Designation  Assistant Professor 
Affiliation  JSS Medical College, JSS Academy of higher education and Research 
Address  Department of Pediatrics JSS Hospital Agrahara, Mysuru
Bannimantap, mysore
Mysore
KARNATAKA
570004
India 
Phone  9742299896  
Fax    
Email  drsushmasri@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical College, Bannimantap, Mysuru 
 
Primary Sponsor  
Name  JSS Medical College 
Address  Bannimantap, mysore 
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 Sushma Krishnegowda  JSS Hospital,mysore  Division of Neonataology, Department of Pediatrics, 2nd floor Agrahara, MG Road, Mysur
Mysore
KARNATAKA 
9742299896

drsushmasri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P285||Respiratory failure of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmeditomedine infusion  Babies in this group will receive Inj. 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 in 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.  
Comparator Agent  morphine infusion  Babies in control group will receive Inj. 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 in 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.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  All term neonates admitted in Neonatal Intensive care requiring Mechanical ventilation
 
 
ExclusionCriteria 
Details  Babies less 36 weeks of gestation, Term babies with Sarnat stage 2 
 
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 pin relief in the first 24 hrs of commencing ventilation and hemodynamical stability during the study period  Time to achieve pin relief in the first 24 hrs of commencing ventilation and hemodynamical stability during the study period 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic instability interns of bradycardia and hypotension needing inotropes  within 24 hrs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Newborn babies require intensive care for various reasonsMechanical ventilation is one of the modes of treatment. It is associated with pain and hence agitation resulting in ventilation dysynchrony. Pain can have impact on the vital parameters and also can have long term morbidities. Hence, Pain relief and in some cases, sedation is necessary to optimize care for critically ill babies and also to facilitate gas exchange. Opioids such as morphine or fentanyl are the commonly used pain relief and sedation as first line in neonatal intensive care units. 

However, these drugs can result in substantial respiratory depression, decreased gastrointestinal motility and hypotension due to vasodilatation. All these effects are seen even at lower therapeutic doses. These adverse effects may lead to prolonged duration of ventilation, hospital stay and eventually increased morbidity. Hence, there a need for a newer drug to have a fine balance between achieving comfort without much of side effect.

Dexmeditomedine is a centrally active alpha receptor agonist having both sedative and analgesic properties. There is evidence to suggest that dexmeditomedine has lesser respiratory depression, no GI side effects and also promotes macrophage activity thereby reducing the sepsis. 

This study was aimed at comparing the Dexmeditomedine infusion with morphine for sedation and pain relief in term ventilated babies.

 
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