Use of Lidocaine-Prilocaine Cream (EMLA): A Pain- Relieving Strategy in Infant Vaccination

Resumen

Background: Vaccination-associated pain is a significant source of distress for infants and their caregivers. Lidocaine–prilocaine cream (EMLA®) is a eutectic mixture topical anaesthetic that offers a pharmacological approach to mitigating procedural pain. Despite its established efficacy in other paediatric procedures, its role in routine infant immunisation requires further contextual evidence, particularly in South Asian settings.

Objectives: To assess the efficacy of EMLA® cream in reducing pain during routine vaccination in infants aged 0–24 months using validated pain scales, to evaluate behavioural responses (consolability and irritability), and to measure parental satisfaction with the pain management strategy.

Methods: A cross-sectional comparative study was conducted over one year in the Department of Paediatrics, Shri Sathya Sai Medical College and Research Institute, Tamil Nadu, India. A total of 182 infants were enrolled and allocated to either the EMLA® group (n = 91) or the control group (n = 91). EMLA® cream was applied 30–60 minutes before vaccination under an occlusive dressing. Pain was assessed using the Neonatal Infant Pain Scale (NIPS) and the Face, Legs, Activity, Cry, Consolability (FLACC) scale at three time points: immediately, 5 minutes, and 30 minutes post-vaccination. Behavioural outcomes and parental satisfaction were also recorded.

Results: EMLA® application resulted in significantly lower NIPS and FLACC scores at all three time points compared to the control group (p < 0.001). Immediately post-vaccination, the mean NIPS score in the EMLA® group was 2.8 ± 1.1 versus 4.9 ± 1.3 in controls. Infants in the EMLA® group were more easily consoled (81.3% vs. 47.3%) and demonstrated less prolonged irritability (6.6% vs. 26.4%). Parental satisfaction scores were significantly higher in the EMLA® group (8.4 ± 1.1 vs. 5.6 ± 1.8, p < 0.001). Minor local skin reactions were noted in 4.4% of the EMLA® group with no systemic adverse events.

Conclusion: EMLA® cream is a safe, effective, and well-accepted pharmacological intervention for reducing pain, behavioural distress, and parental anxiety during routine infant vaccination. Integration into national immunisation programmes should be considered, particularly in settings with high vaccine hesitancy driven by procedure-related pain.