A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery

Summary

The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.

Timeline

Start

2002-11

Primary completion

—

Completion

2003-02

Outcome

Met primary endpoint

paper Tramadol/APAP was superior to tramadol (P < 0.001) or placebo (P < 0.001) on all efficacy measures PMID 15157685 ↗

paper This study established the superiority of tramadol/APAP 75 mg/650 mg over tramadol 100 mg in the treatment of acute pain following oral surgery. PMID 15157685 ↗

Publications

• Results Fricke JR Jr, Hewitt DJ, Jordan DM, Fisher A, Rosenthal NR. A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain. Pain. 2004 Jun;109(3):250-257. doi: 10.1016/j.pain.2004.01.004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.