ULTRACET® Effective And Well Tolerated For Post-Surgical Pain

Apr 5 2004

A new study published in the latest edition of a leading medical journal has shown that treatment with ULTRACET® (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) demonstrates similar efficacy and better tolerability than TYLENOL® with Codeine No. 3 when each is compared to placebo.

Study results published in the April issue of American Journal of Surgery found that pain associated with orthopedic or abdominal surgery was successfully reduced following treatment with ULTRACET®, a leading combination pain reliever marketed by Ortho-McNeil Pharmaceutical, Inc. In an overall review, 69 percent of patients taking ULTRACET® rated it as very good or good compared with 62 percent of patients who were prescribed TYLENOL® with Codeine No. 3.

"Treating pain following surgery with narcotics including TYLENOL® with Codeine No. 3 has long been the preferred method of health care professionals, but this often leaves patients in a state of immobility due to narcotic side effects, like fatigue, nausea or abdominal discomfort," said Adam B. Smith, D.O., Department of Surgery, University of North Texas Health Science Center, Fort Worth, Texas. "This study found that ULTRACET® delivers efficacy but with fewer side effects."

The rate of constipation for patients treated with ULTRACET® was less than half the rate experienced by patients treated with TYLENOL® with Codeine No. 3, (4.1 percent versus 10.1 percent). Also, patients treated with ULTRACET® experienced less vomiting (9.2 percent versus 14.7 percent) and discontinuation due to adverse events (8.2 percent versus 10.1 percent) than in patients treated with TYLENOL® with Codeine No. 3.

This multicenter, randomized, double-blind, placebo-controlled trial evaluated ULTRACET in 153 orthopedic patients (arthroscopic procedure of the knee or shoulder) and 152 abdominal surgery patients (inguinal or ventral hernia repair) for post-surgical pain. Patients with moderate pain or greater were treated with ULTRACET®, TYLENOL® with Codeine No. 3 or placebo. Outcome measures were pain relief and pain intensity. The study was supported by Ortho-McNeil Pharmaceutical, Inc.

ULTRACET® combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET® combination of tramadol and acetaminophen provides faster onset, longer duration and better pain relief over either medication alone.