Use of Pain Medicine to reduce pain during vaccination

Randomized Controlled Trial to Evaluate the Effect of Lignocaine Prilocaine Topical Cream in Breastfed Infants for Reducing Pain during Pentavalent Vaccination in Ambulatory setting - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113572

Enrollment

Registered

2026-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

Intervention1: Lignocaine Prilocaine topical cream: Application of lignocaine prilocaine topical cream over one minute at the injection site 15 minutes prior to vaccination Infant will begin breastfee

Eligibility

Inclusion criteria

Inclusion criteria: Infants whose mothers are willing to breastfeed during the procedure

Exclusion criteria

Exclusion criteria: Infants with acute illness or fever Infants with contraindication to breastfeeding Infants with known allergy to lignocaine or prilocaine Infants who received any analgesic medication 24 hrs prior to vaccination Infants with neurological or developmental disorders affecting pain response

Design outcomes

Primary

Measure	Time frame
Pain score measured using the Neonatal Infant Pain ScaleTimepoint: Pain score measured using the Neonatal Infant Pain Scale at Baseline, during procedure, at end of procedure and at 5 minutes	—

Secondary

Measure	Time frame
Maternal satisfaction using a 5-point Likert scaleTimepoint: Recorded 5 minutes after the procedure	—

Countries

India

Contacts

Public ContactSuvechchha Maity

AIIMS Deoghar

somu_somu@yahoo.com9825087842

Outcome results