A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injection in four to six-year-old children

Acta Paediatr. 2001 Nov;90(11):1329-36. doi: 10.1080/080352501317130416.


The effectiveness of a eutectic mixture lidocaine-prilocaine topical anaesthetic cream (EMLA) patch compared with a placebo patch in the reduction of pain associated with intramuscular immunization was evaluated. As part of the study, 161 children (aged 4-6-y) undergoing routine diphtheria, pertussis, tetanus and polio (DPTP) immunization in five urban and five rural private office settings were randomly assigned to an EMLA patch (n = 83) or a placebo patch control group (n = 78). Pain measurements included: child's self-report on a Faces Pain Scale; facial action on the Child Facial Coding System; the Children's Hospital of Eastern Ontario Pain Scale and parent and technician ratings on a Visual Analogue Scale. Parents also rated their own and their child's immunization-related anxiety on a Visual Analogue Scale. The EMLA patch group had significantly less pain on all four pain measures compared with the placebo group. Of the children in the placebo group, 43% had clinically significant pain, compared with 17% of children in the EMLA patch group. No severe adverse symptoms occurred as a result of either EMLA or placebo patch application.

Conclusion: The EMLA patch reduced immunization pain in 4 to 6-y-old children during needle injection.

Publication types

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

MeSH terms

  • Anesthetics, Combined / therapeutic use*
  • Child
  • Child, Preschool
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Double-Blind Method
  • Drug Combinations
  • Humans
  • Immunization
  • Injections, Intramuscular / adverse effects*
  • Lidocaine / adverse effects
  • Lidocaine / therapeutic use*
  • Lidocaine, Prilocaine Drug Combination
  • Ointments
  • Pain / etiology*
  • Pain / prevention & control*
  • Poliovirus Vaccines / administration & dosage
  • Prilocaine / adverse effects
  • Prilocaine / therapeutic use*
  • Statistics, Nonparametric


  • Anesthetics, Combined
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Drug Combinations
  • Lidocaine, Prilocaine Drug Combination
  • Ointments
  • Poliovirus Vaccines
  • Prilocaine
  • Lidocaine