Safety of EMLA Cream in Newborn Infants
abstract & commentary
Synopsis: One-hour application of 1.0 g of EMLA cream is safe when used on the intact skin of term neonates younger than 3 months of age.
Source: Brisman M, et al. Acta Paediatr 1998;87:1191-1194.
Increasing concerns about pain-inducing medical or diagnostic procedures has led to increasing use of topical analgesics in infants and children. The most widely used topical analgesic is EMLA cream, a eutectic mixture of lidocaine and prilocaine. When applied to the skin approximately one hour before a painful procedure such as venipuncture, objective assessments have shown a reduction of signs of discomfort and pain in treated infants and children compared to controls.1 EMLA cream, because of prilocaine, has a possible side effect of the formation of methomeglobin in a patient’s blood. Newborn infants, especially premature infants, have low levels of cytochrome reductase, which is necessary for the reduction of methemoglobin. Therefore, infants are considered to be more susceptible to methemoglobin-inducing agents than older children.2 Accordingly, EMLA has not been generally recommended for use in the newborn.
Brisman and associates conducted a controlled study of the safety of EMLA cream in term neonates. Forty-seven neonates between 0 and 3 months of age were randomized to have either 1.0 g of EMLA cream or a placebo cream applied to their intact skin for 60-70 minutes. Venous levels of methemoglobin were measured at baseline and at three randomly assigned times, 0.5-18 hours after application. Following application of the creams, the mean methemoglobin level of the EMLA group was 1.17% (range, 0.05-2.53%) compared to a mean of 0.96% (range, 0.50-1.53%) in the placebo group. Blood methemoglobin concentrations of the EMLA group were significantly higher than the controls from 3.5 to 13 hours after application. All of the levels were well below potentially harmful levels. Brisman et al conclude that a local one-hour application of 1.0 g of EMLA cream is safe when used on the intact skin of term neonates younger than 3 months of age. Since premature infants were not studied, no recommendations can be made concerning the use of EMLA cream in low-birth-weight babies.
References
1. Kennedy T, et al. Pediatr Adolesc Med Rep 1997;2:46.
2. Ross JD, et al. Blood 1972;23:419-423.
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