Patient-controlled analgesia (PCA) is regularly used to manage pain following major surgery. The fentanyl hydrochloride iontophoretic transdermal system (ITS) was developed to overcome some of the limitations of intravenous (IV) PCA. The small, self-adhesive, needle-free disposable system is applied to the skin on the upper arm or chest and is controlled by patients clicking a button on the device. The authors identified patients who were underwent spinal surgery from 2 prior multicenter, randomized studies and analyzed their data. Of the 1296 patients in the original trials, 170 underwent spine surgery procedures: 90 were randomized to the fentanyl ITS (40 mcg/activation) and 80 to IV PCA morphine (1 mg/dose). More patients treated with the fentanyl ITS rated their method of pain control as "excellent" across all time points, but differences did not reach statistical significance. However, investigators' ratings of "excellent" satisfaction with study treatment were significantly higher for the fentanyl ITS. Discontinuation rates and overall adverse event rates were similar between groups. The only significant difference was that patients treated with the fentanyl ITS had a higher rate of application site reactions than infusion site reactions in the IV PCA morphine group; the reactions were typically mild-to-moderate erythema that resolved shortly after removal of the fentanyl ITS device and did not require further treatment. Ratings of satisfaction with pain control method were consistently higher for the fentanyl ITS than the IV PCA morphine. The 2 groups had a similar safety profile. These results suggest that the fentanyl ITS appears to be a safe, efficacious alternative to IV PCA in spine surgery patients.
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