Study Shows Needle-Free Transdermal System as Effective as IV Pain Pump for Post-Surgical Pain While Giving Patients More Mobility

PHILADELPHIA -- A needle-free, self-contained

fentanyl patient-controlled transdermal system (PCTS) is as effective for

post-surgical pain management as the traditional intravenous pump (IV), while

giving patients more mobility and freeing nurses to devote more time to

patient care. The study led by researchers from Jefferson Medical College of

Thomas Jefferson University, Philadelphia, appears in the March 17, 2004 issue of

the Journal of the American Medical Association (JAMA).

The multi-center study conducted at more than 30 sites nationwide

demonstrated that a button-activated, fentanyl system that delivers pain

medication through the skin could eliminate the need for IVs for post-surgical

pain relief. The study was led by Eugene Viscusi, MD, director of the Acute

Pain Management Service at Thomas Jefferson University Hospital in Philadelphia.

The fentanyl transdermal system would also offer the advantage of a needle-

free, pre-programmed medication system in a small, self-contained unit.

"This is a miracle of miniaturization," said Viscusi, assistant

professor of anesthesiology at Jefferson Medical College of Thomas Jefferson

University.

The system, known as E-TRANS fentanyl PCTS, is approximately the size of a

credit card, self-adherent to the skin, pre-programmed and needle-free. It

delivers pain medication across the skin with a low level electric current

when activated by the patient with a small button on the surface of the

device.

The fentanyl transdermal system could be used for patients with moderate

to severe post-operative pain after most surgeries including joint

replacement, prostate surgery or gynecological procedures, the Jefferson

anesthesiologist said.

"Anyone who has ever had surgery remembers the discomfort of having IVs

and needles," Viscusi said. "This patch system has a huge potential

advantage."

The PCTS, placed on an inpatient's upper arm or chest by adhesive on the

back of the patch, transmits the pain medication through the skin at the push

of a button, explained Viscusi. When the patient pushes the button for

pain, PCTS delivers medication over 10 minutes. The system has a "lock out"

feature so a patient cannot administer more pain medication than is prescribed

for him. The system is replaced every 24 hours as needed.

Without any tubing or equipment to encumber a patient's movement, the

patient can freely move about to perform needed physical therapy, Viscusi

said.

The PCTS could also be a boon to nurses as nursing staff would not have to

spend time setting up an IV and the time-consuming standard pain pump

currently used. This could allow nurses to devote more time to patient care

instead of technology, he said.

The fentanyl patch system studied is currently under review by the U.S.

Food and Drug Administration (FDA) and was developed by Ortho-McNeil

Pharmaceuticals, Inc. and the ALZA Corporation, both subsidiaries of Johnson

and Johnson.

Source: Thomas Jefferson University Hospital

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