Management of pain from heel lance with lidocaine-prilocaine (EMLA) cream:Is it safe and efficacious in preterm infants?

Hospitalized preterm infants undergo multiple painful heel lances. A two-ph ase, randomized, controlled trial was undertaken to determine the safety an d efficacy of lidocaine-prilocaine 5% cream (EMLA, Astra Pharmaceuticals, L .P., Westborough, MA) for relieving pain from heel lance. One hundred twent y infants were randomly assigned to receive 0.5 g of EMLA or placebo cream for 30 minutes (Phase 1) or 60 minutes (Phase 2) before a routine heel lanc e. Efficacy was assessed using the Premature Infant Pain Profile (PIPP). Sa fety was determined by methemoglobin concentration 8 hours after EMLA appli cation and by clinical signs of methemoglobinemia. No significant differenc es existed on PIPP scores between EMLA and placebo groups in Phase 1 (p < . 480) or Phase 2 (p < .831). No infant had any clinical signs of methemoglob inemia. The mean methemoglobin concentration was 1.19% (.47). Approximately 10% of infants had minor skin reactions, and approximately 20% of EMLA-tre ated infants had blanching at the application site. The authors conclude th at EMLA is safe but not efficacious for relieving pain from heel lance in p reterm infants.