Ga. Smith et al., TETRACAINE-LIDOCAINE-PHENYLEPHRINE TOPICAL ANESTHESIA COMPARED WITH LIDOCAINE INFILTRATION DURING REPAIR OF MUCOUS-MEMBRANE LACERATIONS IN CHILDREN, Clinical pediatrics, 37(7), 1998, pp. 405-412
This study compared the effectiveness of a new topical anesthetic, tet
racaine-lidocaine-phenylephrine (TetraLidoPhen), with that of lidocain
e infiltration during repair of mucous membrane lacerations in childre
n. It was conducted in the emergency department of an urban children's
hospital with use of a prospective, randomized, blinded study design.
Participants were 90 children 1 year of age or older with a laceratio
n 5 cm or less in length on or near a mucous membrane that required su
turing. They were randomly assigned to one of two treatment groups, wi
th 45 patients in each group. Pain felt during suturing was scored by
suture technicians, research assistants, a videotape reviewer, parents
, and patients 5 years of age and older using a Visual Analogue Scale
(VAS). Suture technicians, research assistants, a videotape reviewer,
and parents also scored pain using a seven-point Likert scale. In addi
tion, suture technicians completed an Anesthesia Effectiveness scale a
nd a Wound Blanching scale. The laceration was located near the eyes i
n 71 patients (79%), and on or near the lips in 19 (21%). Lidocaine in
filtration performed significantly better than topical TetraLidoPhen i
n comparisons of Likert sco!es of suture technicians (P=0.007), resear
ch assistants (P=0.005), the videotape reviewer (P=0.003), and parents
(P=0.03);Anesthetic Effectiveness scale scores of suture technicians
(P=0.00002; relative risk (RR)=1.83, 95% confidence interval 1.36<RR<2
,46); and VAS scores of suture technicians (P=0.002), research assista
nts (P=0.001), and the videotape reviewer (P=0.005), No significant di
fference in performance was detected between lidocaine and TetraLidoPh
en in comparing VAS scores of parents and patients. There was a 4.4% w
ound complication rate, including two (2.2%) wound infections, The aut
hors conclude that TetraLidoPhen isa new topical anesthetic that appea
rs to be safe when applied on or near mucous membranes. Its performanc
e among study participants was statistically inferior to that of lidoc
aine infiltration; however the differences in pain scores were small a
nd may not be clinically significant. Also, comparisons of pain scores
in this study did not take into account the pain associated with the
initial injection of lidocaine. Therefore, study findings may underest
imate the comparative performance of TetraLidoPhen. Further investigat
ion of this new topical anesthetic is warranted.