Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

Viatris

Status and phase: Completed; Phase 4

Conditions: Arthroscopy

Treatments: Drug: Celecoxib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633438

A3191067

Details and patient eligibility

About

To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients

Enrollment: 204 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria:

• Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
• Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion criteria

Exclusion criteria:

• Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
• Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
• Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups, including a placebo group

B

Placebo Comparator group

Treatment:

Other: Placebo

A

Experimental group

Treatment:

Drug: Celecoxib