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| |  IARS: Transdermal Device Compares Well with IV Patient Controlled Analgesia By Roberta Friedman, PhD Special to DG News SAN DIEGO, CA -- March 19, 2002 -- A transdermal device that delivers patient-controlled doses of fentanyl through the skin without needles is as effective as patient controlled analgesia with intravenous morphine, suggest results presented here on Sunday, March 17 at the 76th Clinical and Scientific Congress of the International Anesthesia Research Society. Dr. Eugene Viscusi of Thomas Jefferson Medical College in Philadelphia, Pennsylvania, described the results of a study of 636 patients having general or regional anesthesia for major abdominal, orthopedic, or thoracic surgery. After titration to comfort with incremental doses of opioid, patients were randomized to either the transdermal system or conventional IV morphine as patient controlled analgesia (PCA). The transdermal system, being developed by ALZA Corp., delivers 40 micrograms of fentanyl over a ten minute period for up to six doses an hour. Two-thirds the size of a credit card, the device uses iontophoresis to move charged fentanyl across the skin. Placed on the upper arm or upper chest, the patch has a recessed button area the size of a dime that the patient must double click to activate. It functions for 24 hours, or until 80 doses are dispatched. Morphine as a 1mg bolus with a 5-minute lockout was allowed at maximum dose of 10 mg an hour. Rescue fentanyl or morphine was allowed for the first three hours. No other analgesics were permitted. The study was powered to determine equivalence of the patch to conventional morphine PCA, with 24-hour patient global assessment as the primary efficacy parameter. Patch fentanyl was equivalent to IV PCA morphine as an analgesic, with about three-fourths of each group rating the treatment as good or excellent. No statistically significant differences appeared in the number of patients who discontinued either treatment within three hours due to inadequate pain relief (about 14.2 percent and 9.5 percent in the fentanyl and IV morphine groups, respectively). Adverse events included nausea, headache, pruritus, vomiting, constipation, and dizziness. The patch did incur application site erythema in half of the patients who used it. PCA resulted in one case of respiratory depression. Viscusi said the good news is the patch works just like PCA, and the bad news is, it works just like PCA. The issues with PCA are the mechanical failures and the familiar opiate side effects. Abuse potential exists for the patch, yet someone can go through a unit and siphon off IV bags as well as steal patches, he said. The FDA will ask for medical supervision initially for the patch. An advantage of the patch is it can be used during an MRI. Cost of the unit is not yet determined. A Phase IIIB trial is in progress for joint replacements.
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