Purpose: The purpose of this study was to evaluate the effectiveness o
f a single-unit-dose package of the EMLA(R) Patch for dermal analgesia
during intravenous cannulation in adult outpatients and in preventing
vaso-vagal side effects. Methods: After giving consent, 51 ASA I-III
adult outpatients participated in a randomized, double-blind, placebo-
controlled, parallel-group trial to receive either an EMLA(R) or place
bo patch applied to the intravenous cannula site For 60 to 90 min, Fol
lowing cannula insertion, patients and investigators rated the pain us
ing a 100 mm VAS ruler. The incidence and severity of vaso-vagal respo
nses, local skin reactions, and willingness to pay for the patch were
also evaluated. Results: The median VAS pain score by patient assessme
nt in the EMLA(R) patch group was lower (8 mm; range: 0-92) than in th
e placebo group (25 mm : range: 0-98, P < 0.05). The median VAS pain s
core by Investigator assessment was also lower in the EMLA patch group
(15 mm : range 1-79) than in the placebo group (23 mm: range 3-8, P <
0.05). There was a notable difference in the number of vaso-vagal rea
ctions (17 placebo vs 4 EMLA(R), P < 0.05), Eighty-eight percent of pa
tients who received the EMLA(R)-patch would be willing to pay for the
patch in the future compared with 69% of the placebo patch patients. C
onclusion: This study showed that the EMLA(R) patch, applied for 60-90
min before venous cannulation reduced the pain of venepuncture and va
so-vagal side effects in adult outpatients.