Tramadol HCl/acetaminophen for treatment of musculoskeletal pain
 

Overview:  The purpose of this study is to evaluate the safety and effectiveness of tramadol HCl/acetaminophen in subjects who have acute pain from an ankle sprain requiring prescription medication.
 

Primary Endpoints: Patient pain as assessed by VAS

Eligible Patients: Patients over 18 presenting with an acute ankle sprain. Patients may not be pregnant, and must not have received previous pain medications prior to ED visit. The patient is also ineligible if they have any side effects associated with Tramadol HCl/acetaminophen or Vicodin, have a history of kidney problems, are intoxicated at time of presentation to ED, or take medications to prevent seizures, treat depression or to relax muscles (within the past month).
 

Study Design: Prospective observational trial
 

Anticipated Benefits: Improvement of pain, compensation of $175 (upon satisfactory completion of study), cost of study medication and all procedures not part of routine care will be complementary.
 

Potential Risks: Side effects of Tramadol HCl/acetaminophen (constipation, sleepiness, increased sweating, diarrhea, dizziness, dry mouth, pruritus, and may enhance risk of seizure.
 

Research Associate’s Role: RA's trained to enroll patients in the ankle study is responsible for identifying, enrolling, and collecting data from eligible patients for this study. RA's must have the PMP physician in charge of the patient verify the inclusion and exclusion criteria prior to enrollment.
 

Physician’s Role: If patient is willing to participate in the study, the RA will ask you make a final determination on the patient’s eligibility. There are a number of disqualifying criteria for the study that you will be asked to review before agreeing to the patients entry in the study. If you decide that the patient is still eligible, the RA will complete the data collection on the study.
 

Location of Study Packets: Media Room