Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority 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.
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BibTeX
@article{jiravisitkul2026shortened,
title = {{Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority trial}},
author = {Paveewan Jiravisitkul and Manunya Tandhansakul and Chanikarn Thongkam and Saraiorn Thonginnetra},
journal = {World Journal of Clinical Pediatrics},
year = {2026},
month = nov,
doi = {10.5409/wjcp.123652},
url = {https://doi.org/10.5409/wjcp.123652},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority trial
AU - Paveewan Jiravisitkul
AU - Manunya Tandhansakul
AU - Chanikarn Thongkam
AU - Saraiorn Thonginnetra
PY - 2026
DA - 2026/11/03
JO - World Journal of Clinical Pediatrics
DO - 10.5409/wjcp.123652
UR - https://doi.org/10.5409/wjcp.123652
AB - 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.
SN - 2219-2808
ER -