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

BMC Musculoskeletal Disorders

Dimitris A Papanicolaou⁵  Sean P Curtis⁵  Denesh K Chitkara⁵  Anish Mehta¹  Sandhya Shah⁵  Liang Chen⁴  Harold S Minkowitz³  Paul M Peloso⁵  Eugene Viscusi⁶  Narinder Rawal² 

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

[2]Department of Anaesthesiology and Intensive Care, Orebro University Hospital, Örebro, SE 701 85, Sweden

[3]Memorial Hermann Memorial City Medical Center, Houston, TX, USA

[4]Late Development Statistics, Merck & Co., Inc, Whitehouse Station, NJ, USA

[5]Clinical Research, Merck & Co., Inc, Whitehouse Station, NJ, USA

[6]Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA, USA

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

Others  :  1129388
DOI  :  10.1186/1471-2474-14-300

 received in 2012-09-28, accepted in 2013-09-18,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Rawal et al.; licensee BioMed Central Ltd.

【 图 表 】

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