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
Condition: Surgery, Oral; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      While other studies have shown the effectiveness and safety of tramadol/acetaminophen and of
      tramadol alone in treating pain following oral surgery, a direct comparison of the two
      treatments within the same study at these dose levels has not be performed. This is a
      single-center, randomized, double-blind, active- and placebo-controlled, single-dose,
      parallel-group study of adult patients who undergo oral surgery for removal of two or more
      impacted third molars. Patients who have at least moderate pain within 5 hours after surgery
      will be given a single oral dose of 2 capsules of study medication. Patients will be equally
      assigned to receive a total dose of either tramadol HCl 75 mg/acetaminophen 650 mg or
      tramadol HCl 100 mg or placebo. Patients will be asked about the intensity of the current
      pain and pain relief from the starting pain at 30 minutes and at 1, 2, 3, 4, 5 and 6 hours
      after taking the study medication. Patients will also be given two stopwatches that will be
      started once medication has been taken. Patients will stop the first stopwatch when they
      first notice any pain decrease; they will stop the second stopwatch when they notice
      meaningful pain relief. The primary efficacy endpoints are summary measures of hourly patient
      reported pain relief (PAR) and pain intensity scores: total PAR (TOTPAR), sum of hourly pain
      intensity differences (PIDs) from baseline (SPID), and sum of hourly PAR plus hourly PIDs
      from baseline (SPRID). The study hypothesis is that pain relief with tramadol
      HCl/acetaminophen (ULTRACET®) is superior to pain relief from tramadol HCl (ULTRAM®) alone
      after oral surgery and the combination is well tolerated.

      2 capsules, total dose either tramadol HCl 75 milligrams/acetaminophen 650 milligrams,
      tramadol HCl 100 milligrams, or matching placebo taken one time orally; all study medication
      is over-capsulated to match.
    

Intervention name(s): tramadol hydrochloride + acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Oral Surgery; Analgesics; Postoperative Pain; dental