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To evaluate the efficacy and safety of the jet-injected lidocaine device (J-Tip), investigators randomized children aged 1–6 years undergoing outpatient venipuncture to one of three groups: 1) intervention — J-Tip loaded with 0.2 mL of 1% buffered lidocaine, followed by a spray of normal saline; 2) control — vapocoolant spray per institution protocol; or 3) sham — empty J-Tip plus vapocoolant spray. Two independent reviewers blinded to group assignment viewed video recordings and graded patients' pain on a 10-point observational scale at baseline, initiation of device or spray, and during venipuncture.
Overall, 96 children received the intervention, 53 control, and 56 sham treatment. From initiation of the device to venipuncture, pain scores…