- Included patients had uncomplicated arthroscopic ACL reconstruction
- Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm
visual analogue scale (VAS) and moderate to severe pain on a categorical scale by
23:00 hours on the day of surgery and prior to being discharged from the surgical
facility
- Subjects could not have received any medication or additional procedures that would
confound the interpretation of the study results.
- the patient was admitted to or retained in the surgical center/hospital for >23 hours;
- the patient underwent any other surgical procedure, along with the orthopedic
procedure, that was expected to produce a greater degree of surgical trauma than the
orthopedic procedure alone;
- the patient used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective
cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery,
during surgery, or subsequent to the end of surgery;
- the patient received oxaprozin or piroxicam within 1 week prior to randomization;
- the patient had a pain pump or indwelling catheter during surgery that administered
local or intraarticular anesthetics or narcotics at the index joint, or had such an
intra-articular injection at the end of surgery;
- the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to
the end of anesthesia;
- patient had a history of clinically significant GI disease or renal disease, or
history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would
suggest it was not in the subject's best interest to enroll in the trial.