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Local application EMLA cream (local anaesthetic) and Breastfeeding for reducing pain due to wDPT vaccination

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/06/001783
Enrollment
90
Registered
2011-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: EMLA cream: Single application of 1 gm to be applied for 60 minutes on anterolateral aspect of thigh. Control Intervention1: placebo: Single application of 1 gm placebo to be applied fo

Sponsors

LLRM Medical College
Lead Sponsor

Eligibility

Inclusion 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

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 age 4.Preterm deliveries (<37 week of gestation ) 5.Previous surgery

Design outcomes

Primary

MeasureTime frame
Duration of first cry in infants observed for 3 minutesTimepoint: Just after the DPT vaccination

Secondary

MeasureTime frame
Latency of onset of cry Modified neonatal Facial Coding ScoreTimepoint: Just after DPT vaccination

Countries

India

Contacts

Public ContactDr Amit Upadhyay
anuamit7@rediffmail.com09837405009

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026