Lidocaine + prilocaine before 3 months of age: new indication. Correct use is crucial.

(1) The lidocaine + prilocaine combination, as a cream or adhesive dressings, is now approved for anaesthesia of healthy skin in children of 0 to 3 months, an age range in which it used to be contraindicated. (2) The clinical file on the lidocaine + prilocaine combination in this age range is of acceptable methodological quality. (3) For circumcision, two trials showed that the lidocaine + prilocaine cream was more effective than a placebo cream in preventing pain. Two other trials showed that the lidocaine + prilocaine cream was less effective than penile block or local anaesthetic injection in newborns. (4) During heel blood sampling in newborns, the two available comparative trials showed no analgesic efficacy of the lidocaine + prilocaine combination. However, heel blood sampling is an unnecessary procedure. (5) The two comparative trials involving venepuncture in newborns showed, at best, a moderate analgesic effect of the lidocaine + prilocaine combination. (6) Cases of symptomatic methaemoglobinaemia have occurred when recommended conditions of use are not observed.