Research Study Begins on Promising ON-Q Post-Surgical Pain Relief Device, New for Pediatric Patients

Published on: 02/17/2004

LAKE FOREST, CA. — I-Flow Corporation (NASDAQ: IFLO), today announced that Miami Children's Hospital is beginning a study of ON-Q for postsurgical pain relief in pediatric patients undergoing surgical cardiac procedures for repair of congenital defects. The goal of the study is to deter-mine if the benefits of a continuous infusion of local anesthetic with the ON-Q Post-Operative Pain Relief System, that have been proven in adult patients, will be experienced in patients aged three months and older. The study will examine the effects of ON-Q on variables including their level of pain, length of hospital stay, amount of additional analgesia needed to control pain, satisfaction of post-operative pain relief and the amount of medication absorbed.


Post-surgical pain is often controlled with narcotics such as morphine, but these drugs can result in unfavorable side effects including difficulty breathing, nausea and vomiting and can cause patients to remain hospitalized longer. ON-Q, an effective non-narcotic surgical-site pain relief device, has been shown to reduce the need for narcotics in adult surgical patients by an average of 40 to 70 percent, depending on the procedure. This often enables patients to leave the hospital days earlier than when treated just with narcotics so they can return to their normal lives faster after surgery.


The Principal Investigator of the study is Christopher F. Tirotta, MD, MBA, Director of Cardiovascular Anesthesia, who is working closely with co-investigators Redmond Burke, MD, Chief of Cardiovascular Surgery, and Robert Hannan, NM, all of Miami Children's Hospital. In this randomized, double-blind study, the ON-Q pump will be used with all patients whose parents give permission for them to volunteer to participate. Half of the ON-Q pumps will be filled with a local anesthetic to be delivered to the surgical site and the other half will be filled with a placebo (saline). All patients will receive the same outstanding care at Miami Children's Hospital, whether they participate in the study or not.

"Pediatric pain management is a significant challenge due in part to the reluctance and at times to the inability of patients to ask for pain medication, as well as the unwillingness of doctors to administer adequate doses of narcotics," said Dr. Tirotta. "With this study we hope to see a reduced need for narcotics during the post-operative period, demonstrating that site-specific pain relief can not only improve in-hospital care, but also lead to a faster recovery and discharge."

 

"Thousands of pediatric cardiac surgeries are performed each year at hospitals like Miami Children's," said Donald M. Earhart, president and CEO of I-Flow Corporation. "We are committed to helping surgical patients return to their everyday activities faster and we are optimistic that this study will prove that ON-Q can play a key role in post-surgical pain relief for even the youngest of patients."
 

About ON-Q

The ON-Q Post-Operative Pain Relief System provides targeted pain relief after surgery only where the body needs it, delivering a non-narcotic numbing medication directly to an incision site. ON-Q consists of a small, high-tech balloon pump that delivers local anesthetic, a pain-numbing medication, directly to the surgical site for up to five days. The anesthetic is administered through a tiny specially-designed tube (catheter) that's inserted by a surgeon during surgery. ON-Q is cleared for use by the U.S. Food & Drug Administration (FDA).

ON-Q can deliver narcotic-free pain relief for many surgeries, including: cesarean sections, hysterectomies, knee replacements, mastectomies, cardiovascular/thoracic procedures, foot and ankle surgeries and many cosmetic surgeries. A growing body of clinical information is becoming available for ON-Q for many different surgeries. For more information about ON-Q, visit www.AskYourSurgeon.com or call 800-448-3569.
 

About the Congenital Heart Institute at Miami Children's Hospital

Since its inception in 1996, the 28-bed Heart Institute has cared for more than 2,000 infants and children admitted from around the country and the world. The Congenital Heart Institute at Miami Children's is comprised of the Cardiac Intensive Care Unit (CICU), along with the division of cardiovascular surgery, the cardiac catheterization laboratory, and the heart station.
 

About I-Flow Corporation

I-Flow Corporation (www.iflo.com) designs, develops and markets technically advanced drug delivery systems that are redefining the standard of care by providing life enhancing, cost effective solutions for pain relief.

Certain disclosures made by the Company in this press release and in other reports and statements released by the Company are and will be forward-looking in nature, such as comments that express the Company's opinions about trends and factors that may impact future operating results. Disclosures that use words such as the Company "believes, " 'anticipates, " or "expects " or use similar expressions are intended to identify'forward-looking statements. Forward-looking statements are subject to certain risks and uncertain ties, which could cause actual results to differ from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this release which seek to advise interested parties of the risks and other factors that affect the Company's business, as well as in the Company's periodic reports on Forms 10-K, JO-Q, and 8-Kfiled with the Securities and Exchange Commission. The risks affecting the Company's business include reliance on the success of the home health care industry, the Company's success in pursuing its direct sales strategy, the reimbursement system currently in place and future changes to that system, competition in the industry, economic and political conditions in foreign countries, currency exchange rates, inadequacy of booked reserves, technological changes and product availability. Any such forward-looking statements, whether made in this release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.


About Nicklaus Children's Hospital

Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital is South Florida's only licensed specialty hospital exclusively for children, with nearly 800 attending physicians and more than 475 pediatric subspecialists. The 309-bed hospital, known as Miami Children's Hospital from 1983 through 2014, is renowned for excellence in all aspects of pediatric medicine with many specialty programs routinely ranked among the best in the nation by U.S. News & World Report since 2008. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. For more information, please visit www.nicklauschildrens.org.

© 2020 Nicklaus Children's Hospital. All Rights Reserved.