FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2012/07/002780 [Registered on: 10/07/2012] Trial Registered Retrospectively
Last Modified On: 09/07/2012
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   A clinical trial comparing the vaccination related pain of two different vaccination techniques in children under one and half years. 
Scientific Title of Study   “Vaccination related pain: randomized controlled trial, comparison of pain of two injection techniques” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Girish G N 
Designation  Junior Resident in Pediatrics 
Affiliation  JSS Medical College, JSS University, Mysore 
Address  No.1, 8th main, T Block – 1 Bogadi 2nd stage (south), Mysore Karnataka

Mysore
KARNATAKA
570026
India 
Phone  9886974232  
Fax    
Email  girish.gn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M D Ravi 
Designation  Professor in Pediatrics 
Affiliation  JSS Medical College, JSS University, Mysore 
Address  Department of Pediatrics, JSS Medical College Hospital, Ramanuja Road, Mysore, Karnataka

Mysore
KARNATAKA
570004
India 
Phone  9880629506  
Fax    
Email  ravimdped@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Girish G N 
Designation  Junior Resident in Pediatrics 
Affiliation  JSS Medical College, JSS University, Mysore 
Address  No.1, 8th main, T Block – 1 Bogadi 2nd stage (south), Mysore Karnataka

Mysore
KARNATAKA
570026
India 
Phone  9886974232  
Fax    
Email  girish.gn@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics, JSS Medical College, Ramanuja Road, Mysore, Karnataka, India 
 
Primary Sponsor  
Name  JSS Medical college  
Address  Department of Pediatrics, JSS Medical College hospital, Ramanuja Road, Mysore - 570004 Karnataka, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr M D Ravi  Vice Principal and Professor of Pediatrics, JSS medical College hospital,Ramanuja road, Mysore, Karnataka 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish G N  JSS medical college Hospital  Department of Pediatrics, JSS Hospital, Ramanuja road, Mysore
Mysore
KARNATAKA 
9886974232

girish.gn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pain during vaccination 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Changing the vaccination technique  Standard group received immunisation using standard slow technique with aspiration and Pragmatic group received immunisation using “pragmatic” technique where needle advanced fast, injected without aspiration and needle was withdrawn fast. whole procedure was completed in 1-2 sec. 
Comparator Agent  Standard vaccination technique  Standard vaccination technique of slow advancement of needle followed by aspiration, injection and then slow removal of needle. whole process was completed in 5- 10 sec 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  18.00 Month(s)
Gender  Both 
Details  All healthy infants of age group 6 weeks to one and half years receiving routine intramuscular DTwP vaccination. 
 
ExclusionCriteria 
Details  Any criteria which precludes immunization. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measured was immediate infant pain response assessed using the Modified Behavior Pain Score which was scored from the videotape analysis.  post immunization pain score within 15 sec of the immunization  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures included infant crying time assessed from videotapes.  start of cry to till it ends 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2008 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Methodology: In this Randomised Controlled Trial, source of data were 200 healthy infants of age group 6 weeks to one and half years, receiving routine intramuscular vaccination. They were divided randomly using computer generated random numbers into Standard group receiving immunisation using standard slow technique with aspiration and Pragmatic group receiving immunisation using “pragmatic” technique without aspiration. The entire vaccination procedure was videotaped. Videos were scored for pain using Modified Behavior Pain Score by 2 clinical psychologists and the mean score was considered for analysis. Pain was scored within 15 s of the immunization were measured and described the child’s maximal pain response to the injection. Cry time was measured from the start of cry till it ends by a different person. Entire data was entered in a preformed proforma. The Z test for two sample population means was used for statistical analysis.

Results: Standard technique required a longer duration (5-10 sec) when compared to pragmatic technique (1-2 sec). Mean Post vaccination MBPS in standard Group was 8.4 and in Pragmatic Group was 7.8 which was statistically significant. Crying duration in pragmatic group was less (32.1 sec) than standard group (37.37sec).

Conclusion: The “standard” slow technique was significantly more painful and took longer to administer than the “pragmatic” rapid technique.

 
Close