A randomized, controlled trial to evaluate topical anesthetic for 15 minutes before venipuncture in pediatrics.

OBJECTIVES

The aim of the study was to assess the differences in reported pain from venipuncture comparing liposomal 4% lidocaine with placebo cream in a pediatric population. Other factors assessed were patient anxiety, difficulty of venipuncture, and history of venipuncture.

METHODS

A prospective, randomized, double-blind, placebo control study design was used in which subjects were assigned to receive either liposomal 4% lidocaine or placebo cream. The study population consisted of pediatric patients aged 5 to 18 years old who presented to 1 site of a multisite, academic, community emergency department. Once subjects had consented and randomized, the liposomal 4% lidocaine or placebo cream was applied for 15 minutes under occlusion. A 6-point validated FACES pain scale was used to evaluate each patient's level of pain during venipuncture. Patient anxiety was evaluated using a 100-mm visual analogue scale before, during, and after the venipuncture. Heart rate was captured as an indirect measurement of pain.

RESULTS

There were no significant differences between the study and placebo groups (P > .05) in mean levels of patient ratings of anxiety, patient heart rate, or the patient's mean rating of pain before, during, or after the venipuncture procedure. There was an association between increased anxiety with an increase in venipuncture pain and an inverse association between age and pain.

CONCLUSION

Topical liposomal 4% lidocaine cream in this case did not prove to be effective with a 15-minute dwell time under occlusion because there were no differences in pain between study groups.