RANDOMIZED CONTROLLED TRIAL OF EUTECTIC MIXTURE OF LOCAL-ANESTHETICS CREAM FOR VENIPUNCTURE IN HEALTHY PRETERM INFANTS

Aim-To assess the safety and efficacy of EMLA cream (eutectic mixture of local anaesthetics) used to induce surface anaesthesia for venepunc ture in healthy preterm infants. Methods-Nineteen infants, median gest ational age 31 weeks (range 26-33 weeks) were assessed in a randomised , double blind, placebo controlled, crossover trial. Changes in physio logical variables (heart rate, blood pressure, oxygen saturation) and behavioural responses (neonatal facial coding system score, crying tim e) before and after venepuncture with EMLA cream were compared with th ose obtained with a placebo cream to assess efficacy. Toxicity was ass essed by comparing methaemoglobin concentrations at 1 hour and 8 hours after application.Results-There was no significant difference in effi cacy between EMLA and placebo creams in physiological and behavioural responses. There was no significant difference in methaemoglobin conce ntrations one hour after the cream had been applied. At eight hours, h owever, concentrations were significantly higher after EMLA than place bo (p=0.016). There was no evidence of clinical toxicity. Conclusion-T his study does not support the routine use of EMLA for venepuncture in healthy preterm infants.