| 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
|
|
|
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
|
|
|
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 opioidâ€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. |