Amethocaine-lidocaine cream, a new topical formulation for preventing venopuncture-induced pain in children.

BACKGROUND AND OBJECTIVES: The aim of this study was to compare the effectiveness of 3 anesthetic creams in relieving venous puncture-related pain in children.

METHODS: We performed a double-blind, randomized, prospective study in 300 patients, American Society of Anesthesiologists (ASA) I-II, aged 3 months to 10 years, scheduled for minor elective surgical procedures. These children were distributed into 3 groups, with 100 patients each, according to each type of cream applied to the back of the children's hands before performing the venous puncture: Group I was given EMLA (eutectic 2.5% lidocaine and 2.5% prilocaine mixture), group II received 4% amethocaine (4% AMET), and group III was treated with AMLI (2.5% amethocaine and 2.5% lidocaine), a new anesthetic cream developed at our hospital. Each group was further classified into 5 subgroups, with 20 patients each, according to the time length of the application of the individual cream (group A, < or = 30 minutes; B, 30 minutes to 60 minutes; C, 60 minutes to 90 minutes; D, 90 minutes to 120 minutes; E, > or = 120 minutes). We evaluated pain, movement, and verbalization to puncture, as well as the appearance of adverse effects.

RESULTS: Group I (EMLA), subgroup A (< or = 30 minutes), experienced significantly more pain, movement, and verbalization than groups II and III. Patients in group II (4% AMET) exhibited a higher frequency of untoward effects.

CONCLUSIONS: All 3 creams proved to be effective in relieving venous puncture pain in children. EMLA presented a longer latency period, 4% amethocaine showed the highest percentage of untoward effects, and AMLI exhibited a shorter latency period than EMLA, while having fewer adverse effects than 4% AMET and EMLA.