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

Figure 1 Consolidated Standards of Reporting Trials flow diagram showing participant enrollment, allocation, follow-up, and analysis. A total of 150 children were recruited and randomized into two groups: 74 were allocated to group A and received a eutectic mixture of lidocaine and prilocaine (EMLA) for 40 minutes, and 76 were allocated to group B and received the EMLA for 20 minutes plus skin cooling for 30 seconds. All participants completed the follow-up and were included in the intention-to-treat analysis. Three participants in group A were excluded from the per-protocol analysis due to minor protocol deviations (EMLA application duration shorter than the predefined per-protocol threshold). EMLA: Eutectic mixture of lidocaine and prilocaine; ITT: Intention-to-treat. Claude (Anthropic, San Francisco, CA, United States) was used to generate the foundational digital layouts and structural frameworks for this figure.