| 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
|
|
|
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
|
|
|
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 reasons. Mechanical 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. |