In this randomized, double-blinded, placebo-controlled study, we evaluated the safety and efficacy of lidocaine iontophoresis for the prevention of pain associated with venipuncture in 59 children aged 6-17 yr. Children received either lidocaine HCl 2% with epinephrine 1:100,000 (Active) or the same formulation without lidocaine (Placebo) via a 20 mA/min iontophoretic treatment. Pain during venipuncture was assessed by the subject, parent, and nurse using a 100-mm visual analog scale. Median (interquartile range) visual analog scale scores were significantly lower in the Active versus Placebo groups: subject, 7.0 (2.0-20.8) versus 31.0 (12.0-48.0), P < 0.001; nurse, 5.0 (2.2-10.8) versus 24.0 (9.0-47.0), P < 0.001; and parent, 3.0 (0.8-7.2) versus 20.0 (4.5-43.0), P < 0.002, respectively. Similarly, higher median satisfaction scores were given to the Active versus Placebo group by the three evaluators. Of the 59 subjects completing the study, 10 subjects experienced a total of 12 adverse events that were all graded as mild. In conclusion, lidocaine iontophoresis is safe in children, reduces discomfort associated with venipuncture, and increases satisfaction when compared with the placebo.
Implications: In this randomized, double-blinded, placebo-controlled study, we found that dermal anesthesia with lidocaine HCl 2% combined with epinephrine 1:100,000 administered via iontophoresis in children is achieved in 8.8 +/- 2.1 min, reduces discomfort associated with venipuncture, is safe, and increases satisfaction when compared with the placebo.