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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  
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 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  
Status 
Not Applicable 
 
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.

 
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