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The safety and tolerability of the fentanyl HCl iontophoretic transdermal system: An alternative to currently available analgesic modalities

Leopold Eberhart, MD

Abstract


Background and objective: The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is an analgesic modality approved for the management of acute postoperative pain. The fentanyl ITS uses a generally imperceptible electrical field to drive fentanyl across the skin and into the bloodstream. Unlike intravenous patient-controlled analgesia (PCA), fentanyl ITS is needle free and preprogrammed, eliminating the risks of needlestick injury and programming errors. Its efficacy, safety, and tolerability were assessed in several clinical trials, and this article presents the integrated safety and tolerability of fentanyl ITS using data pooled from these studies.
Methods: Data were pooled from three placebocontrolled trials and one active-controlled trial (fentanyl ITS vs intravenous PCA morphine) in which patients 18 years or older were admitted to the postanesthesia care unit after major abdominal, orthopedic, or thoracic surgery.
Results: This analysis of safety and tolerability data revealed common treatment-related adverse events: nausea, vomiting, headache, and erythema. No clinically relevant respiratory depression was observed. No significant differences were observed between elderly patients (≥65 years of age) and patients <65 years of age.
Conclusion: The fentanyl ITS addresses certain safety issues of existing modalities while providing comparable pain relief, making it an attractive option for postoperative pain management.

Keywords


fentanyl, iontophoresis, patient-controlled analgesia, postoperative pain

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References


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DOI: https://doi.org/10.5055/jom.2007.0012

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