Work

Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND Vaccination is a cornerstone of pediatric primary care; however, injection-site pain remains a barrier to acceptance and on-time uptake. While applying a eutectic mixture of lidocaine and prilocaine (EMLA) can reduce pain, its 30-60 minutes onset is impractical in high-volume primary-care settings. Brief skin cooling, which reduces peripheral nerve conduction, is effective within seconds and may complement a shortened EMLA application time without compromising analgesia. AIM To determine whether 20-minute EMLA plus 30-second ice-pack cooling is non-inferior to the standard 40-minute EMLA for pediatric vaccination pain. METHODS A single-center, parallel-group, open-label, randomized, controlled, non-inferiority trial was conducted with 150 children aged 4-15 years who received a quadrivalent inactivated influenza vaccine (Vaxigrip Tetra, southern-hemisphere formulation; Sanofi Pasteur, Lyon, France). The primary endpoint was the self-reported Wong-Baker FACES Pain Rating Scale score immediately after injection. The non-inferiority margin was +1.4 points (one-sided α = 0.025). An intention-to-treat analysis was performed, with a per-protocol sensitivity check. RESULTS All 150 children completed the follow-up (74 in the standard group and 76 in the intervention group). The adjusted mean difference in the pain score immediately after injection (intervention group minus standard group) was -0.30 points (95% confidence interval: -1.00 to 0.50). The upper limit of the 95% confidence interval was below the prespecified non-inferiority margin of +1.4 points. The median preparation time fell from 47 minutes to 27 minutes. All adverse events were grade 1, according to the Common Terminology Criteria for Adverse Events, and self-resolving. Exploratory analyses suggested that there were fewer mild events at 15 minutes in the intervention group (25.0% vs 45.9%, P = 0.010). Caregiver satisfaction was high in both groups. CONCLUSION The 20-minute EMLA plus brief skin-cooling regimen was non-inferior to the standard 40-minute regimen for managing pediatric vaccination pain and reduced the preparation time by a median of 20 minutes.

Source: World Journal of Clinical Pediatrics

DOI: 10.5409/wjcp.123652

Authors: Paveewan Jiravisitkul, Manunya Tandhansakul, Chanikarn Thongkam, Saraiorn Thonginnetra

Institutions: Chulabhorn Hospital, Chulabhorn Royal Academy

Language: English

Topic: Pediatric Pain Management Techniques

Subfield: Pediatrics, Perinatology and Child Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: diamond

Funder: Chulabhorn Royal Academy