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Open Access Highly Accessed Research article

Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial

Narinder Rawal1*, Eugene Viscusi2, Paul M Peloso3, Harold S Minkowitz4, Liang Chen5, Sandhya Shah3, Anish Mehta6, Denesh K Chitkara3, Sean P Curtis3 and Dimitris A Papanicolaou3

Author Affiliations

1 Department of Anaesthesiology and Intensive Care, Orebro University Hospital, Örebro, SE 701 85, Sweden

2 Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA, USA

3 Clinical Research, Merck & Co., Inc, Whitehouse Station, NJ, USA

4 Memorial Hermann Memorial City Medical Center, Houston, TX, USA

5 Late Development Statistics, Merck & Co., Inc, Whitehouse Station, NJ, USA

6 Office of the Chief Medical Officer, Merck & Co., Inc, Whitehouse Station, NJ, USA

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BMC Musculoskeletal Disorders 2013, 14:300  doi:10.1186/1471-2474-14-300

Published: 24 October 2013

Abstract

Background

Optimal postoperative pain management is important to ensure patient comfort and early mobilization.

Methods

In this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0–10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1–3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1–3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated.

Results

The least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1–3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1–3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively.

Conclusions

Postoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.

Clinical trial registration

NCT00820027

Keywords:
Etoricoxib; Ibuprofen; Morphine consumption; Total knee replacement; Pain at rest; Pain upon movement