FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081266 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study Comparing Topical Emla and physical pain blocker for pain reduction in neonates during vaccination. 
Scientific Title of Study   Comparative assessment of pain reduction with topical EMLA and physical pain blocker in primary whole cell DPT vaccination using neonatal infant pain scale -an open labelled randomized control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amrin Taaj I 
Designation  postgraduate student 
Affiliation  vinayaka missions medical college and hospital,karaikal 
Address  room no 2 first floor paediatrics opd building vinayaka missions medical college and hospital karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  09600068501  
Fax    
Email  amrintaaj.at@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinoth Selvaraj 
Designation  Associate professor 
Affiliation  vinayaka missions medical college and hospital,karaikal 
Address  room no 3 first floor paediatrics opd building vinayaka missions medical college and hospital karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  9080220712  
Fax    
Email  rajkantmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amrin Taaj I 
Designation  postgraduate student 
Affiliation  vinayaka missions medical college and hospital,karaikal 
Address  room no 2 first floor paediatrics opd building vinayaka missions medical college and hospital karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  09600068501  
Fax    
Email  amrintaaj.at@gmail.com  
 
Source of Monetary or Material Support  
vinayaka missions research foundation - deemed university NH47, sankari main road,Salem , Tamil Nadu, India -636308 
 
Primary Sponsor  
Name  vinayaka missions research foundation deemed university 
Address  NH47 sankari main road salem 636308 
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 
Dramrin taaj I  vinayaka missions medical college and hospital  room no 2 first floor paediatrics opd building vinayaka missions medical college and hospital
Karaikal
PONDICHERRY 		 09600068501

amrintaaj.at@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee of Vinayaka Missions medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preventive intervention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  physical pain blocker  brand - painblocky ONE7HEALTHCARE p ltd it is a handheld device with blunt points which is pressed against skin during vaccination. Works immediately with no waiting time. it is used at the time of vaccination and removed after administration of vaccination. 
Comparator Agent  topical anaesthetic prilocaine- lignocaine   brand name - EMLA 30GM TUBE ZENECA ASTRA prilocaine 2.5 % lignocaine 2.5% with applicator and tegaderm . it is applied 30 minutes prior to vaccination. 
 
Inclusion Criteria  
Age From  1.50 Month(s)
Age To  3.50 Month(s)
Gender  Both 
Details  healthy infants of 6,10- and 14-weeks gestation. 
 
ExclusionCriteria 
Details  1)infants who are nicu graduates
2)infants with congenital anomalies, dysmorphism, hearing or vision abnormalities identified at birth
3)infants who suffer from illness which are acute or may extend long term.
4)infants on medications other than vitamin supplements. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
pain reduction comparison between emla cream and physical pain blocker.  assessed at the time of vaccination administered at 6weeks,10 weeks and 14 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of pain at 6th,10th & 14th week of life  assessed at the time of vaccination administered at 6weeks 10 weeks & 14 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/03/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amrintaaj.at@gmail.com].

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   immunization is an important cost effective public health intervention to control vaccine preventable infectious diseases among children. Though pharmacological interventions are available to reduce pain of vaccine pricks , they are not widely practiced in India due to high burden on health care infrastructure and manpower.in this setting nonpharmacological methods which are safe, easily available, more accessible and acceptable may prove useful if their physiological actions are understood and efficacy proven by trials.

In this regard, this study intends to compare pain reduction efficacy of physical method of using pain blocker with standard topical EMLA (eutectic mixture of local anesthetics) cream application for vaccination pain associated with whole cell Diphtheria Pertussis Tetanus containing pentavalent vaccine for the three primary doses. The pain would be measured with standard NIPS (NEONATAL INFANT PAIN SCALE).
 
Close