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Director of NIPF UICH Project, University of Illinois Medical Center, Chicago, IL
To the Editor:
I must comment on the paper of Lysakowski et al. (1). This study was neither appropriately randomized nor was a valid assessment of the cost/benefit ratio made. The authors used saline as a placebo, without realizing that its pH is too acid and therefore irritates the skin, which is confirmed by the pain score NVS 4.2 in the saline and 3.9 in the nontreatment group. The commonly used 25-gauge needle/syringe should have been utilized in the control group. The major cause of the poor results is the lack of buffering the lidocaine. There are multiple misstatements of costs in their article, e.g., $23.00 for 1% lidocaine in the Abstract and $4.69 in Table 2, $10.00 for the 2% in the Abstract and $4.82 in Table 2.
Their findings are contrary to published reports (2–4) that with jet injection of midazolam, ketamine, and lidocaine, none of the children or adults experienced pain greater than 1 on a visual analog scale. During the past 3 years, in over 100,000 jet-local anesthesia injections, zero pain scores were consistently observed in our hospital. Furthermore, our cost of skin local anesthesia with the J-tip syringe is matching the combined cost of a safety needle and syringe.
References
Division of Anesthesiology, Geneva University Hospitals, Geneva, Switzerland
In Response:
Dr. Zsigmond seems to be concerned about the internal and external validity of our study on the usefulness of jet injection with lidocaine (1). We would like to respond to his queries.
First, as mentioned in the Methods section of our article, we were using a computer-generated random number table to allocate patients to one of the four study groups; thus, our study was indeed appropriately randomized. Adequate randomization is important, since it controls for selection bias.
Second, Dr. Zsigmond seems to confound pain on jet application (NVS >3 in 19.5% of the patients who received a jet injection) and pain on cannula insertion (average NVS 4.2 with saline, NVS 3.9 with no treatment). As we pointed out in our study, there was no difference in pain on cannula insertion between the placebo (saline) group and the no treatment group, indicating that the saline per se had no impact on pain intensity with cannula insertion.
Third, Dr. Zsigmond seems to confound total cost ($4.69 for jet with lidocaine 1%, and $ 4.82 for jet with lidocaine 2%) with incremental cost effectiveness ratios (for patients with a NVS = 3 on catheter insertion: $23 for jet with lidocaine 1%, and $10 for jet with lidocaine 2%). As pointed out in our article, it is important for rational decision making to estimate the costs incurred to generate one patient who is profiting from a change in clinical practice from doing nothing (i.e., from not using any analgesic treatment) to applying the jet. Thus, incremental cost-effectiveness ratios are indeed a valid assessment of cost-benefit ratios.
Finally, we do agree with Dr. Zsigmond that a control group with a 25-gauge needle would add further information. Our primary aim was to evaluate the usefulness of the jet injector compared with doing nothing. As a next step, a head-to-head comparison with a widely used analgesic procedure may be an option. However, our study showed very nicely that with lidocaine-jet, costs incurred to achieve one success compared with doing nothing were not negligible. It follows as a logical consequence that if we compared lidocaine-jet with a truly analgesic intervention (for instance, lidocaine through a 25-gauge needle), incremental cost-effectiveness ratios would be even less favorable.
Reference
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