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.


CONCLUSIONS
The EMLA patch reduced immunization pain in 4 to 6-y-old children during needle injection.
Cassidy
K L
KL
Department of Medicine, Izaak Walton Killam Health Centre, and Dalhousie University, Halifax, Nova Scotia, Canada. kcassidy@istar.ca
Reid
G J
GJ
McGrath
P J
PJ
Smith
D J
DJ
Brown
T L
TL
Finley
G A
GA
D019162:Anesthetics, Combined / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D007114:Immunization; D007273:Injections, Intramuscular / Q000009:adverse effects*; D008012:Lidocaine / Q000009:adverse effects / Q000627:therapeutic use*; D000077442:Lidocaine, Prilocaine Drug Combination; D009824:Ointments; D010146:Pain / Q000209:etiology* / Q000517:prevention & control*; D023321:Poliovirus Vaccines / Q000008:administration & dosage; D011318:Prilocaine / Q000009:adverse effects / Q000627:therapeutic use*; D018709:Statistics, Nonparametric
D019162:Anesthetics, Combined; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004338:Drug Combinations; D000077442:Lidocaine, Prilocaine Drug Combination; D009824:Ointments; D023321:Poliovirus Vaccines; D011318:Prilocaine; D008012:Lidocaine