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TOPICAL LOCAL ANAESTHETIC SPRAY WITH VAPOCOOLANT VERSUS EMLA CREAM IN INFANTS DURING VACCINATION

A PROSPECTIVE RANDOMISED CONTROLLED TRIAL COMPARING THE EFFICACY OF TOPICAL LOCAL ANAESTHETIC SPRAY WITH VAPOCOOLANT VERSUS EMLA CREAM FOR PAIN ALLEVIATION IN INFANTS DURING VACCINATION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033426
Enrollment
228
Registered
2021-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Topical Local Anesthetic Spray with Vapocoolant: Topical local anaesthetic spray with vapocoolant will have benzocaine 0.36% along with polyvinyl polymer 2.52% in a propellant solvent.

Sponsors

DR AYUSH JAIN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All healthy infants of age group 9-11 weeks brought for immunization with 2nd dose of Liquid Pentavalent Vaccine

Exclusion criteria

Exclusion criteria: 1) Infants with any painful lesion or condition 2) Infants receiving treatment with methaemoglobin-inducing agents 3) Infants on medications which can alter pain perception and response 4) Neurologically depressed infants due to any condition 5) Severe allergic reaction to a vaccine component or following a prior dose of a vaccine 6) History of reaction following application of topical anaesthetic agent

Design outcomes

Primary

MeasureTime frame
To compare the pain reduction efficacy of the topical local anaesthetic spray with vapocoolant and EMLA cream during vaccination to childrenTimepoint: 0 minute, 1 minute and 5 minutes after injection—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDR TANMAYA METGUD

JAWAHARLAL NEHRU MEDICAL COLLEGE, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH

tanmayametgud@gmail.com9845395294

Outcome results

None listed

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