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

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.