| CTRI Number |
CTRI/2011/06/001783 [Registered on: 03/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
03/06/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Local application EMLA cream (local anaesthetic) and Breastfeeding for reducing pain due to wDPT vaccination
|
|
Scientific Title of Study
|
Comparision of the antinociceptive effect of topical EMLA cream with breast feeding, topical EMLA cream with distilled water & topical placebo cream with distilled water, during first DPT vaccination in healthy term infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Upadhyay |
| Designation |
Head of Department |
| Affiliation |
|
| Address |
Deptt. of Pediatrics
L.L.R.M.Medical College,Meerut
Meerut
UTTAR PRADESH
Nil
India |
| Phone |
09837405009 |
| Fax |
|
| Email |
anuamit7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Upadhyay |
| Designation |
Head of Department |
| Affiliation |
|
| Address |
Deptt. of Pediatrics
L.L.R.M.Medical College,Meerut
Meerut
UTTAR PRADESH
Nil
India |
| Phone |
09837405009 |
| Fax |
|
| Email |
anuamit7@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Upadhyay |
| Designation |
Head of Department |
| Affiliation |
|
| Address |
Deptt. of Pediatrics
L.L.R.M.Medical College,Meerut
Meerut
UTTAR PRADESH
Nil
India |
| Phone |
09837405009 |
| Fax |
|
| Email |
anuamit7@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Lala Lajpat Rai Memorial Medical College, Meerut, UP, India
|
|
|
Primary Sponsor
|
| Name |
LLRM Medical College |
| Address |
LLRM Medical College
Meerut (UP) |
| Type of Sponsor |
Government 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 Nav Ratan Kumar Gupta |
Immunization clinic |
Deptt. of Pediatrics,L.L.R.M.Medical College, Meerut-
Meerut
UTTAR PRADESH |
09457660060
navratankumargupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee LLRM Medical College, Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DPT Vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMLA cream |
Single application of 1 gm to be applied for 60 minutes on anterolateral aspect of thigh. |
| Comparator Agent |
placebo |
Single application of 1 gm placebo to be applied for 60 minutes on anterolateral aspect of thigh. |
|
|
Inclusion Criteria
|
| Age From |
1.50 Month(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Full term healthy infant, less than three months of postnatal age, either exclusive or partially breast fed, who will attend the immunization clinic for first DPTvaccine according to universal immunization program |
|
| ExclusionCriteria |
| Details |
1.All infants who have required hospital admission more than 48 hrs.
2.Preinatal asphyxia (5 min Apgar Score <5) or delayed cry if born at home.
3.Intrauterine growth retardation (IUGR) i.e wt <10th centile for gestational age
4.Preterm deliveries (<37 week of gestation )
5.Previous surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of first cry in infants observed for 3 minutes |
Just after the DPT vaccination
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Latency of onset of cry
Modified neonatal Facial Coding Score |
Just after DPT vaccination |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2009 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Abstract
Objective: To compare efficacy in pain reduction due to wDPT using (a) EMLA cream along with breast feeding (EB group) and (b) EMLA cream with oral distilled water (EW group) as compared to placebo cream with oral distilled water (PCW group). Methods: Design: A Randomized, double blind, placebo controlled trial. Setting: The immunization clinic of Department of Pediatrics, LLRM Medical College, Meerut. Participants: Infants less than 3months of age who visited immunization clinic for their 1st DPT vaccination, they were randomized in three groups of 30 each. Outcome measure: The primary outcome variable was the duration of cry after vaccination. Secondary outcome variables were latency of onset of cry and Modified Facial Coding Score.
Results: 30 babies were enrolled in each of 3 groups. Median (IQR) of duration of cry was least 34.6 (24.1-72.2) seconds in EB group, followed by 94.2 (46.1-180) seconds in EW group as compared to 180.0 (180-180) seconds in PCW group (P<0.05). Mean (95%CI) of latency of cry was significantly more in EB group 2.4 (1.9-2.8) seconds) and EW group 1.9(1.7-2.1) seconds) as compared to babies in PCW 1.5 (1.3-1.6) seconds) (P<0.05) but the difference between EB and EW group was not significant. Modified Facial Coding Score at 1min and 3min was significantly lower in EB group as compared to EW and PCW group(P<0.05).
Conclusions: Topical EMLA application is effective in reducing pain due to DPT vaccination in young infants up to 3 months of age. It has synergistic effect in analgesia when combined with breast feeding during vaccination.
|