Article Reviews & Commentary
Article Reviews by Thomas J. Mancuso, MD, FAAP
A Clinical Study to Evaluate the Efficacy
of ELA-Max as Compared with EMLA Cream for Pain Reduction of Venipuncture
in Children.
Eichenfeld LF, Funk A Fallon-Freidlander S et al
Pediatrics 2002:109;1093-1099
This double-randomized, blinded crossover trial compared EMLA with ELA-Max (4% liposomal lidocaine). One hundred twenty children, 5-17 years of age scheduled for venipuncture, were studied and doubly randomized to treatment and length of time of application. EMLA was always used with occlusion, ELA-Max was used both with and without occlusion. Outcome measurements were the child's VAS rating and an observers rating using the Observed Behavioral Distress scores. Neither the demographics of the children within the different groups nor the difficulty of venipuncture differed significantly.
There was no clinically or statistically significant differences between the treatment groups VAS scores. ELA-Max provided similar analgesia as EMLA with occlusion based on OBSD scores by parents or observers. Application of ELA-Max for 30 minutes, in this study, was safe and as effective as 60 minutes of EMLA with occlusion in ameliorating pain associated with venipuncture. Skin reactions were rarely seen in any of the subjects and seen least often in the ELA-max without occlusion.
Commentary
In a many cases, 60 minutes is often too long a time to wait to place an IV. Based on these results, this new product which provides analgesia without occlusion in 30 minutes will make the placement of IV's in patients seen in a busy preop area much more comfortable for all concerned. Many of us have noted vasoconstriction in the veins beneath EMLA. Unfortunately, the authors did not comment about the presence or absence of this phenomena in any of the subjects in this study. #include ./footer_include.iphtml