Pain, Postoperative
Conditions
Keywords
anterior cruciate ligament, arthroscopy, knee, post-surgical pain
Brief summary
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.
Interventions
DRUGvaldecoxib
valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
DRUGdiclofenac
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study * In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and moderate to severe pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included
Exclusion criteria
* Patient was scheduled to undergo 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 was undergoing bilateral knee arthroscopy * The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization * The patient received oxaprozin or piroxicam within one week prior to randomization * The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study * The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Assessment of Pain - Visual Analogue Scale | Days 1-6 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Days 1-6 |
| Vital signs | Screening, Day 1, and Day 6 |
| Consumption of Rescue Medication | Days 1-6 |
| Modified Brief Pain Inventory - short form | Days 2-6 |
| Global Evaluation of Study Medication | Days 1-6 |
| Effect on Pain Medication Questionnaire and Health Resource Utilization | Days 2-6 |
| Physical examination | Screening and Day 6 |
Countries
Australia, Hong Kong, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand
Outcome results
None listed