Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Clin Pediatr. Dec 9, 2026; 15(4): 123652
Published online Dec 9, 2026. doi: 10.5409/wjcp.123652
Published online Dec 9, 2026. doi: 10.5409/wjcp.123652
Shortened eutectic mixture of lidocaine and prilocaine plus skin cooling for pediatric vaccination pain: A randomized non-inferiority trial
Paveewan Jiravisitkul, Manunya Tandhansakul, Department of Pediatrics, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok 10210, Thailand
Chanikarn Thongkam, Division of Outpatient Department, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok 10210, Thailand
Saraiorn Thonginnetra, Princess Srisavanggavadhana Faculty of Medicine, Chulabhorn Royal Academy, Bangkok 10210, Thailand
Author contributions: Jiravisitkul P and Thonginnetra S designed the research and wrote the manuscript; Jiravisitkul P, Tandhansakul M, Thongkam C, and Thonginnetra S performed the research and collected the data; Jiravisitkul P and Thonginnetra S analyzed the data; Thonginnetra S verified the underlying data and supervised the statistical analysis. All authors reviewed and approved the final manuscript.
AI contribution statement: AI tools were used solely for linguistic refinement and assistance with figure layout. ChatGPT (GPT-4 model; OpenAI, San Francisco, CA, United States) was used for English language editing to improve clarity and fluency. Claude (Anthropic, San Francisco, CA, United States) was used to generate the foundational digital layouts and structural frameworks for Figures 1, 2, and 3. No AI tool was used in the study design, data generation, statistical analysis, interpretation of results, or formulation of conclusions. All AI-generated outputs were critically reviewed and revised by the authors, in accordance with the guidelines of the International Committee of Medical Journal Editors and the Committee on Publication Ethics.
Supported by Chulabhorn Royal Academy through the Research Excellence Group Funding Programmed of Chulabhorn Hospital, Chulabhorn Royal Academy, No. 544/2568.
Institutional review board statement: The study protocol was approved by the Ethics Committee of Chulabhorn Royal Academy on April 11, 2025 (approval No. EC 016/2568).
Clinical trial registration statement: This study was prospectively registered with the Thai Clinical Trials Registry (https://www.thaiclinicaltrials.org) on February 2, 2025 (TCTR20250202006).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: De-identified individual participant data and the study protocol are available from the corresponding author upon reasonable request, subject to institutional approval.
Corresponding author: Paveewan Jiravisitkul, MD, Principal Investigator, Department of Pediatrics, Chulabhorn Hospital, Chulabhorn Royal Academy, 906 Kamphaeng Phet 6 Road, Talat Bang Khen Subdistrict, Lak Si, Bangkok 10210, Thailand. paveewan.jir@cra.ac.th
Received: May 25, 2026
Revised: July 10, 2026
Accepted: July 28, 2026
Published online: December 9, 2026
Processing time: 116 Days and 22.1 Hours
Revised: July 10, 2026
Accepted: July 28, 2026
Published online: December 9, 2026
Processing time: 116 Days and 22.1 Hours
Core Tip
Core Tip: In this single-center, open-label, randomized non-inferiority trial conducted with 150 children aged 4-15 years who received a quadrivalent influenza vaccine, a 20-minute topical application of a eutectic mixture of lidocaine and prilocaine combined with 30 seconds of ice-pack skin cooling met the prespecified non-inferiority criterion for post-injection pain when compared with the standard 40-minute eutectic mixture of lidocaine and prilocaine regimen. The intervention reduced the preparation time by a median of 20 minutes. Exploratory analyses suggested fewer mild adverse events at 15 minutes, and caregiver satisfaction was high in both groups. This pragmatic, low-cost protocol is suitable for high-volume primary-care vaccination services.