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-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.
Stevens
B
B
Faculties of Nursing and Medicine, University of Toronto, Department of Pediatrics, The Hospital for Sick Children, Ontario, Canada. bonnie.stevens@utoronto.ca
Johnston
C
C
Taddio
A
A
Jack
A
A
Narciso
J
J
Stremler
R
R
Koren
G
G
Aranda
J
J
D019162:Anesthetics, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D006365:Heel / Q000293:injuries*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D000077442:Lidocaine, Prilocaine Drug Combination; D008708:Methemoglobinemia / Q000097:blood; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D011318:Prilocaine / Q000008:administration & dosage* / Q000009:adverse effects; D011677:Punctures / Q000009:adverse effects*
D019162:Anesthetics, Combined; D000779:Anesthetics, Local; D000077442:Lidocaine, Prilocaine Drug Combination; D011318:Prilocaine; D008012:Lidocaine