CTRI Number |
CTRI/2019/12/022572 [Registered on: 31/12/2019] Trial Registered Prospectively |
Last Modified On: |
24/12/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Rapidness of Analgesic effect of sucrose |
Scientific Title of Study
|
Randomized control trial to compare effect of time after sucrose administration on preterm neonatal pain control during heel prick |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Somashekhar Nimbalkar |
Designation |
Professor of Pediatrics |
Affiliation |
Pramukhswami Medical College |
Address |
Ground floor, HM Patel Academic center, Gokalnagar, Karamsad, Anand
Anand GUJARAT 388325 India |
Phone |
09825087842 |
Fax |
|
Email |
somu_somu@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Somashekhar Nimbalkar |
Designation |
Professor of Pediatrics |
Affiliation |
Pramukhswami Medical College |
Address |
Ground floor, HM Patel Academic center, Gokalnagar, Karamsad, Anand
Anand GUJARAT 388325 India |
Phone |
09825087842 |
Fax |
|
Email |
somu_somu@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Somashekhar Nimbalkar |
Designation |
Professor of Pediatrics |
Affiliation |
Pramukhswami Medical College |
Address |
Ground Floor, HM Patel Academic center, Goklanagar, KAramsad, Anand
Anand GUJARAT 388325 India |
Phone |
09825087842 |
Fax |
|
Email |
somu_somu@yahoo.com |
|
Source of Monetary or Material Support
|
Pramukhswami Medical College, Karamsad, Anand, Gujarat |
|
Primary Sponsor
|
Name |
Pramukhswami Medical College |
Address |
Department of Pediatrics, Pramukhswami Medical College, Gokalnagar,Karamsad, Anand, Gujarat |
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 Dipen Patel |
Neonatal Intensive Care Unit, Shree Krishna Hospital |
NICU, First floor, Shree Krishna Hospital,Pramukhswami medical college, gokalnagar, karamsad,anand Anand GUJARAT |
9825331453
dipen_patel258@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee-2 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Sucrose at 1 minute |
Sucrose given 1 minute before heelprick |
Intervention |
Sucrose at 15 seconds |
Scurose given 15 seconds before heel prick |
Comparator Agent |
Sucrose at 2 minutes |
Sucrose given at 2 minutes before heelprick |
Intervention |
Sucrose at 30 seconds |
Sucrose given 30 seconds befoer heelprick |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
90.00 Day(s) |
Gender |
Both |
Details |
All neonates with gestation from 28 weeks to 36 weeks |
|
ExclusionCriteria |
Details |
Neonates on invasive ventilator (non cpap)
Clinically evident abnormal neurological signs
have received analgesic or sedative in last 24 hours |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
PIPP Score at the end of procedure |
PIPP Score at the end of procedure |
|
Secondary Outcome
|
Outcome |
TimePoints |
None |
None |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
01/01/2020 |
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)?
|
Brief Summary
|
International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage [1]. Repeated painful exposures can have deleterious consequences. These consequences include altered pain sensitivity (which may last into adolescence) and permanent neuroanatomic and behavioral abnormalities, as found in animal studies. Neonates admitted to NICU receive multiple painful procedures as a part of their medical management and care. They are frequently exposed to repeated procedural pain and experience significant stress during critical period of physiological vulnerability and rapid neurological development. Neonates and more predominantly preterm neonates have the nociceptive circuitry but this system is functionally immature [2,3]. Cutaneous nociceptors fields are large in the neonates, and peripheral sensory fibers are extremely sensitive to tissue injury and have reduced peak firing frequencies.[2-5] They also have low discriminatory ability to discriminate between noxious and non-noxious stimuli.[6,7] Subpalate Neurons which are a important of Thalamic efferent circuitry connecting thalamus to cerebral cortex and Preoligiodendrocytes which are precursors to myelin producing oligodendrocytes are particularly vulnerable to pain, and may undergo apoptosis following exictotoxic free radical or inflammatory damage.[8,9] Multiple studies have shown the benefits of sucrose on neonatal pain reduction.[10-12] However, ideal sucrose administration time before the pain stimuli has not been studied adequately. As per previous study in our instutite pain was reduce if sucrose given before 30 seconds,hence we belived that even sucrose given before 15 second of heel prick it would reduce pain so we want to know that sucrose <15 second before the procedure reduces the neonatal pain by randomized control trial to compare effect of time after sucrose administration on preterm neonatal pain control during heel prick. |