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Lidocaine + prilocaine before 3 months of age: new indication. Correct use is crucial
Insights
Lidocaine and prilocaine cream is now approved for infants 0-3 months for skin anesthesia. While effective for circumcision pain compared to placebo, its efficacy is less than other methods for newborn procedures like heel pricks and venipuncture.
Area of Science:
- Pediatric Anesthesiology
- Dermatology
- Pharmacology
Background:
- Lidocaine and prilocaine combination was previously contraindicated for infants aged 0-3 months.
- Recent clinical data supports its use in this age group for skin anesthesia.
- Methodological quality of the clinical file for this age range is acceptable.
Purpose of the Study:
- To evaluate the efficacy and safety of lidocaine and prilocaine for anesthesia in neonates and infants.
- To assess the analgesic effects in procedures like circumcision, heel blood sampling, and venipuncture.
- To review the approved indications for lidocaine and prilocaine in young children.
Main Methods:
- Systematic review of clinical trials and studies on lidocaine and prilocaine.
- Comparative analysis of efficacy against placebo, penile block, and local anesthetic injections.
- Assessment of adverse events, including symptomatic methaemoglobinaemia.
Main Results:
- Lidocaine and prilocaine cream showed efficacy over placebo for circumcision pain prevention.
- Efficacy was lower than penile block or local anesthetic injection for newborn circumcision.
- No significant analgesic effect was observed for heel blood sampling; moderate effect for venipuncture in newborns.
- Symptomatic methaemoglobinaemia occurred when usage conditions were not followed.
Conclusions:
- Lidocaine and prilocaine combination is now approved for skin anesthesia in infants 0-3 months.
- Its effectiveness varies by procedure, being less effective than invasive methods for certain newborn interventions.
- Adherence to recommended usage is crucial to prevent adverse events like methaemoglobinaemia.
Abstract:
(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.
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