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

J Dev Behav Pediatr. 1999 Aug;20(4):216-21. doi: 10.1097/00004703-199908000-00003.


Hospitalized preterm infants undergo multiple painful heel lances. A two-phase, randomized, controlled trial was undertaken to determine the safety and efficacy of lidocaine-prilocaine 5% cream (EMLA, Astra Pharmaceuticals, L.P, Westborough, MA) for relieving pain from heel lance. One hundred twenty 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 lance. Efficacy was assessed using the Premature Infant Pain Profile (PIPP). Safety was determined by methemoglobin concentration 8 hours after EMLA application and by clinical signs of methemoglobinemia. No significant differences 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 methemoglobinemia. The mean methemoglobin concentration was 1.19% (.47). Approximately 10% of infants had minor skin reactions, and approximately 20% of EMLA-treated infants had blanching at the application site. The authors conclude that EMLA is safe but not efficacious for relieving pain from heel lance in preterm infants.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anesthetics, Combined / administration & dosage*
  • Anesthetics, Combined / adverse effects
  • Anesthetics, Local / administration & dosage*
  • Anesthetics, Local / adverse effects
  • Heel / injuries*
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Lidocaine / administration & dosage*
  • Lidocaine / adverse effects
  • Lidocaine, Prilocaine Drug Combination
  • Methemoglobinemia / blood
  • Pain / etiology
  • Pain / prevention & control*
  • Prilocaine / administration & dosage*
  • Prilocaine / adverse effects
  • Punctures / adverse effects*


  • Anesthetics, Combined
  • Anesthetics, Local
  • Lidocaine, Prilocaine Drug Combination
  • Prilocaine
  • Lidocaine