A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain

Current Medical Research and Opinion

Volumn 20, Issue 10, 2004, Pages 1523-1537

  Desjardins, Paul J ^a,b   Black, Peter M ^a,b   Daniels, Steven ^a,b   Bird, Steven R ^a   Fitzgerald, Brian J ^a   Petruschke, Richard A ^a   Tershakovec, Andrew ^a   Chang, David J ^a  

^a Premier Research   (United States)

^b Merck and Co Inc ^*

Author keywords

Acute; Bunionectomy; Diclofenac; Pain; Rofecoxib

Indexed keywords

DICLOFENAC; PLACEBO; ROFECOXIB;

ADULT; ANALGESIA; ARTICLE; BUNIONECTOMY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; ENTERIC COATED TABLET; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PAIN; POSTOPERATIVE PAIN; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SINGLE DRUG DOSE; TABLET; TOTAL PAIN RELIEF OVER 8 HOURS SCORE; VOMITING;

ADMINISTRATION, ORAL; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DICLOFENAC; DOUBLE-BLIND METHOD; FEMALE; HALLUX VALGUS; HUMANS; LACTONES; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; PLACEBOS; SULFONES;

EID: 7644241637     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079904X3069     Document Type: Article

References (44)

1. Fields HL, Martin JB. Pain: pathophysiology and management. In: Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL, editors. Harrison's principles of internal medicine, 15th ed. New York: McGraw-Hill; 2001.p. 55-60
2. Waldman SD. Acute and postoperative pain. Management from a primary care perspective. Postgrad Med 1992 [Spec No:5-18]
3. Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg 2002;10:117-29
4. Joris J. Efficacy of nonsteroidal antiinflammatory drugs in postoperative pain. Acta Anaesthesiol Belg 1996;47:115-23
5. Power I, Barratt S. Analgesic agents for the postoperative period. Nonopioids Surg Clin North Am 1999;79:275-95
6. Stephens J, Laskin B, Pashos C, et al. The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors. Rheumatology (Oxford) 2003;42(Suppl 3);iii:40-52
7. Barkin RL. Acetaminophen, aspirin, or ibuprofen in combination analgesic products. Am J Ther 2001;8:433-42
8. Curatolo M, Sveticic G. Drug combinations in pain treatment: a review of the published evidence and a method for finding the optimal combination. Best Pract Res Clin Anaesthesiol 2002;16:507-19
9. Raffa RB. Pharmacology of oral combination analgesics: rational therapy for pain. J Clin Pharm Ther 2001;26:257-64
10. Philip BK, Reese PR, Burch SR The economic impact of opioids on postoperative pain management. J Clin Anesth 2002;14:354-64
11. Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs 2003;63:649-71
12. Bowdle TA. Adverse effects of opioid agonists and agonist-antagonists in anaesthesia. Drug Saf 1998;19:173-89
13. Daniel NG, Goulet J, Bergeron M, et al. Antiplatelet drugs: is there a surgical risk? J Can Dent Assoc 2002;68:683-7
14. Ruoff G, Lema M. Strategies in pain management: new and potential indications for COX-2 specific inhibitors. J Pain Symptom Manage 2003;25(Suppl 2):S21-31
15. Homoncik M, Malec M, Marsik C, et al. Rofecoxib exerts no effect on platelet plug formation in healthy volunteers. Clin Exp Rheumatol 2003;21:229-31
16. Van Hecken A, Schwartz JI, Depre M, et al. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000;40:1109-20
17. Meade EA, Smith WL, DeWitt DL. Differential inhibition of prostaglandin endoperoxide synthase (cyclooxygenase) isozymes by aspirin and other non-steroidal anti-inflammatory drugs. J Biol Chem 1993;268:6610-4
18. Mitchell JA, Akarasereenont P, Thiermermann C, et al. Selectivity of nonsteroidal anti-inflammatory drugs as inhibitors of constitutive and inducible cyclooxygenase. Proc Natl Acad Sci USA. 1994;90:11693-719.
19. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. New Engl J Med 2000;343:1520-8
20. Reicin A, Brown J, Jove M, et al. Efficacy of single-dose and multidose rofecoxib in the treatment of post-orthopedic surgery pain. Am J Orthop 2001;30:40-8
21. Morrison BW, Fricke J, Brown J, et al. The optimal analgesic dose of rofecoxib: overview of six randomized controlled trials. J Am Dent Assoc 2000;131:1729-37
22. Morrison BW, Christensen S, Yuan W, et al. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther 1999;21:943-53
23. Chang DJ, Fricke JR, Bird SR, et al. Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial. Clin Ther 2001;23:1446-55
24. Malmstrom K, Daniels S, Kotey P, et al. Comparison of rofecoxib and celecoxib, two cyclooxygenase-2 inhibitors, in postoperative dental pain: a randomized, placebo- and active-comparator-controlled clinical trial. Clin Ther 1999;21:1653-63
25. Malmstrom K, Fricke JR, Kotey P, et al. A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental pain impaction model. Clin Ther 2002;24:1549-60
26. Chang DJ, Desjardins PJ, Chen E, et al. Comparison of the analgesic efficacy of rofecoxib and enteric-coated diclofenac sodium in the treatment of postoperative dental pain: a randomized, placebo-controlled clinical trial. Clin Ther 2002;24:490-503
27. Chang DJ, Desjardins PJ, Bird SR, et al. Comparison of rofecoxib and a multidose oxycodone/acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin 2004;20:939-49
28. Desjardins PJ, Black PM, Daniels S, et al. VIOXX (rofecoxib) sustains effectiveness in treatment of postoperative bunionectomy pain. J Pain 2004;5(Suppl 1):S80
29. IMS Health, Fairfield, CT. M1A NSAID Database. NSAID prescriptions and sales volume 4th quarter 2003. http://www.ims-global.com/
30. Desjardins PJ, Black P, Papageorge M, et al. Ibuprofen arginate provides effective relief from postoperative pain with more rapid onset of action than ibuprofen. Eur J Clin Pharmacol 2002;58:387-94
31. Redmond M, Florence B, Glass PS. Effective analgesic modalities for ambulatory patients. Anesthesiol Clin North Am 2003;21:329-46
32. Shang AB, Can TJ. Optimising postoperative pain management in the ambulatory patient. Drugs 2003;63:855-67
33. Gottschalk A, Wu CL, Ochroch EA. Current treatment options for acute pain. Expert Opin Pharmacother 2002;3:1599-611
34. Joshi GP. Postoperative pain management. Int Anesthesiol Clin 1994;32:113-26
35. Desjardins PJ, Shu VS, Recker DP, et al. A single preoperative oral dose of valdecoxib, a new cyclooxygenase-2 specific inhibitor, relieves post-oral surgery or bunionectomy pain. Anesthesiology 2002;97:565-73
36. Desjardins PJ, Chang DJ, Krupa D, et al. Onset of analgesic efficacy of rofecoxib 50 mg: a combined analysis of 11 clinical studies. J Pain;4(Suppl 1)[in press]
37. Kehlet H. Acute pain control and accelerated postoperative surgical recovery. Surg Clin North Am 1999;79:431-43
38. Viscusi ER. Emerging techniques in the treatment of postoperative pain. Am J Health Syst Pharm 2004;61 (Suppl 1):S11-4
39. Ogilvy AJ, Smith G. The gastrointestinal tract after anaesthesia. Eur J Anaesthesiol Suppl 1995;10:35-42
40. Kenny GN. Risk factors for postoperative nausea and vomiting. Anaesthesia 1994;49(Suppl):6-10
41. Katz WA. Cyclooxygenase-2-selective inhibitors in the management of acute and perioperative pain. Cleve Clin J Med 2002;69(Suppl 1):S165-75
42. Bjorkman DJ. The effect of aspirin and nonsteroidal antiinflammatory drugs on prostaglandins. Am J Med 1998;105(1B):8S-12S
43. Schafer AI, Effects of nonsteroidal antiinflammatory drugs on platelet function and systemic hemostasis. J Clin Pharmacol 1995;35:209-19
44. Justins DM, Richardson PH. Clinical management of acute pain. Br Med Bull 1991;47:561-83