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

Abstract

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.