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Study Comparing Topical Emla and physical pain blocker for pain reduction in neonates during vaccination.

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081266
Enrollment
80
Registered
2025-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: 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 wait

Sponsors

vinayaka missions research foundation deemed university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: healthy infants of 6,10- and 14-weeks gestation.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
pain reduction comparison between emla cream and physical pain blocker.Timepoint: assessed at the time of vaccination administered at 6weeks,10 weeks and 14 weeks—

Secondary

MeasureTime frame
comparison of pain at 6th,10th & 14th week of lifeTimepoint: assessed at the time of vaccination administered at 6weeks 10 weeks & 14 weeks—

Countries

India

Contacts

Public ContactAmrin Taaj I

vinayaka missions medical college and hospital,karaikal

rajkantmc@gmail.com9080220712

Outcome results

None listed

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