The safety and tolerability of the fentanyl HCl iontophoretic transdermal system: an alternative to currently available analgesic modalities.
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 placebo-controlled 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 (> or =65 years of age) and patients <65 years of age.


CONCLUSIONS
The fentanyl ITS addresses certain safety issues of existing modalities while providing comparable pain relief making it an attractive option for postoperative pain management.
Eberhart
Leopold
L
Department of Anaesthesiology and Intensive Care, Philipps-University, Marburg, Germany.
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016058:Analgesia, Patient-Controlled; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D007262:Infusions, Intravenous; D007478:Iontophoresis; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy; D020250:Postoperative Nausea and Vomiting / Q000139:chemically induced / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic
D000701:Analgesics, Opioid; D005283:Fentanyl