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Clinical Trials/CTRI/2011/06/001783
CTRI/2011/06/001783
Completed
Phase 4

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

LLRM Medical College1 site in 1 country90 target enrollmentJanuary 10, 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
LLRM Medical College
Enrollment
90
Locations
1
Primary Endpoint
Duration of first cry in infants observed for 3 minutes
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Abstractxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

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, xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /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.

Registry
ctri.nic.in
Start Date
January 10, 2009
End Date
TBD
Last Updated
15 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
LLRM Medical College

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 age4.Preterm deliveries (<37 week of gestation )5.Previous surgery.

Outcomes

Primary Outcomes

Duration of first cry in infants observed for 3 minutes

Time Frame: Just after the DPT vaccination

Secondary Outcomes

  • Latency of onset of cry(Modified neonatal Facial Coding Score)

Study Sites (1)

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