• 1

    Kehlet H, Dahl JB: The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. .Anesth Analg 77::1048. ,1993. .

  • 2

    Bannwarth B: Risk-benefit assessment of opioids in chronic noncancer pain. .Drug Saf 21::283. ,1999. .

  • 3

    Gabriel SE, Jaakkimainen L, Bombardier C: Risk for serious gastrointestinal complications related to use of non-steroidal anti-inflammatory drugs: a meta-analysis. .Ann Intern Med 115::787. ,1991. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4

    Gajraj NM: Cyclooxygenase-2 inhibitors. .Anesth Analg 96::1720. ,2003. .

  • 5

    Garcia Rodriguez LA, Jick H: Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. .Lancet 343::769. ,1994. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6

    Goldstein JL, Silverstein FE, Agrawal NM, et al: Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. .Am J Gastroenterol 95::1681. ,2000. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7

    Harris SI, Kuss M, Hubbard RC, et al: Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. .Clin Ther 23::1422. ,2001. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8

    Kivitz A, Eisen G, Zhao WW, et al: Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. .J Fam Pract 51::530. ,2002. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9

    Sikes DH, Agrawal NM, Zhao WW, et al: Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis. .Eur J Gastroenterol Hepatol 14::1101. ,2002. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10

    Noveck RJ, Laurent A, Kuss M, et al: Parecoxib sodium does not impair platelet function in healthy elderly and non-elderly individuals: two randomised, controlled trials. .Clin Drug Invest 21::465. ,2001. .

    • Search Google Scholar
    • Export Citation
  • 11

    Leese PT, Talwalker S, Kent JD, et al: Valdecoxib does not impair platelet function. .Am J Emerg Med 20::275. ,2002. .

  • 12

    Leese PT, Recker DP, Kent JD: The COX-2 selective inhibitor, valdecoxib, does not impair platelet function in the elderly: results of a randomized controlled trial. .J Clin Pharmacol 43::504. ,2003. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    Broom DC, Samad TA, Kohno T, et al: Cyclooxygenase 2 expression in the spared nerve injury model of neuropathic pain. .Neuroscience 124::891. ,2004. .

  • 14

    Samad TA, Moore KA, Sapirstein A, et al: Interleukin-1β-mediated induction of Cox-2 in the CNS contributes to inflammatory pain hypersensitivity [letter]. .Nature 410::471. ,2001. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Woolf CJ, Costigan M: Transcriptional and posttranslational plasticity and the generation of inflammatory pain. .Proc Natl Acad Sci U S A 96::7723. ,1999. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Woolf CJ, Salter MW: Neuronal plasticity: increasing the gain in pain. .Science 288::1765. ,2000. .

  • 17

    Woolf CJ, Mannion RJ: Neuropathic pain: aetiology, symptoms, mechanisms, and management. .Lancet 353::1959. ,1999. .

  • 18

    Neumann S, Doubell TP, Leslie T, et al: Inflammatory pain hypersensitivity mediated by phenotypic switch in myelinated primary sensory neurons. .Nature 384::360. ,1996. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Seibert K, Zhang Y, Leahy K, et al: Pharmacological and biochemical demonstration of the role of cyclooxygenase 2 in inflammation and pain. .Proc Natl Acad Sci U S A 91::12013. ,1994. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    Hay C, de Belleroche J: Carrageenan-induced hyperalgesia is associated with increased cyclooxygenase-2 expression in spinal cord. .Neuroreport 8::1249. ,1997. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    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 97::565. ,2002. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    Camu F, Beecher T, Recker DP, et al: Valdecoxib, a COX-2-specific inhibitor, is an efficacious, opioid-sparing analgesic in patients undergoing hip arthroplasty. .Am J Ther 9::43. ,2002. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    Reynolds LW, Hoo RK, Brill RJ, et al: The COX-2 specific inhibitor, valdecoxib, is an effective, opioid-sparing analgesic in patients undergoing total knee arthroplasty. .J Pain Symptom Manage 25::133. ,2003. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24

    Joshi GP, Viscusi ER, Gan TJ, et al: Effective treatment of laparoscopic cholecystectomy pain with intravenous followed by oral COX-2 specific inhibitor. .Anesth Analg 98::336. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    Gan TJ, Joshi GP, Zhao SZ, et al: Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. .Acta Anaesthesiol Scand 48::1194. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 26

    Zhao SZ, Chung F, Hanna DB, et al: Dose-response relationship between opioid use and adverse effects after ambulatory surgery. .J Pain Symptom Manage 28::35. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Gan TJ, Joshi GP, Viscusi E, et al: Preoperative parenteral parecoxib and follow-up oral valdecoxib reduce length of stay and improve quality of patient recovery after laparoscopic cholecystectomy surgery. .Anesth Analg 98::1665. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 28

    Jenkins JK, Seligman PJ: Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk [memorandum]. Available at: http://www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf. Accessed June 20. ,2005. .

Analgesic Efficacy of Valdecoxib for Acute Postoperative Pain After Bunionectomy

View More View Less
  • 1 San Antonio Podiatry Associates, San Antonio, TX.
  • | 2 Advanced Regional Center for Clinical Research, Altoona, PA.
  • | 3 Temple University School of Podiatric Medicine, Philadelphia, PA. Dr. Hillstrom is now with the Hospital for Special Surgery, New York, NY.
  • | 4 AGMG Clinical Research, Santa Ana, CA.
  • | 5 Horizon Institute for Clinical Research, Hollywood, FL.
  • | 6 Pfizer Global Research and Development, Ann Arbor, MI.
Restricted access

Two randomized, double-blind, placebo-controlled studies assessed the analgesic efficacy of valdecoxib in patients with moderate-to-severe pain after bunionectomy. Study 1 (N = 374) assessed the efficacy of two regimens of valdecoxib on the day after surgery (valdecoxib, 40 mg, with a 20-mg redose [n = 127]; valdecoxib, 40 mg, with a placebo redose [n = 122]; and placebo/placebo [n = 125]), and study 2 (N = 478) examined the efficacy of two different multiple-dose regimens on postoperative days 2 through 5 (valdecoxib, 20 mg, twice daily [n = 160]; valdecoxib, 20 mg, once daily [n = 159]; and placebo [n = 159]). Valdecoxib provided significant pain relief and reduced the use of opioid rescue medication. This efficacy was accompanied by improved global scores, decreased pain interference with function, and increased patient satisfaction. (J Am Podiatr Med Assoc 96(5): 393–407, 2006)

Corresponding author: Richard Pollak, DPM, MS, San Antonio Podiatry Associates, 8042 Wurzbach Dr, Ste 450, San Antonio, TX 78229.