• 1.

    Acute Pain Management Guideline Panel : “Acute Pain Management: Operative or Medical Procedures and Trauma. ,” inClinical Practice Guideline. ,Agency for Health Care Policy and Research, Public Health Service, US Dept of Health and Human Services. ,Rockville, MD. ,1992. . AHCPR Publication No. 92-0032.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2.

    American Society of Anesthesiologists Task Force on Acute Pain Management :Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. .Anesthesiology 100::1573. ,2004. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Gordon, DB, JL Dahl, C Miaskowski, et al. :American Pain Society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force. .Arch Intern Med 165::1574. ,2005. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Veterans Health Administration, Department of Defense :Clinical practice guideline for the management of postoperative pain .Available at: http://www.oqp.med.va.gov/cpg/PAIN/PAIN_GOL.htm. .Accessed December 28, 2004.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Beauregard, L, A Pomp, and M Choiniere. :Severity and impact of pain after day-surgery. .Can J Anaesth 45::304. ,1998. .

  • 6.

    Dolin, SJ, JN Cashman, and JM Bland. :Effectiveness of acute postoperative pain management: I. Evidence from published data. .Br J Anaesth 89::409. ,2002. .

  • 7.

    McGrath, B, H Elgendy, F Chung, et al. :Thirty percent of patients have moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. .Can J Anaesth 51::886. ,2004. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    McHugh, GA and GM Thoms. :The management of pain following day-case surgery. .Anaesthesia 57::270. ,2002. .

  • 9.

    Rawal, N, J Hylander, PA Nydahl, et al. :Survey of postoperative analgesia following ambulatory surgery. .Acta Anaesthesiol Scand 41::1017. ,1997. .

  • 10.

    MacIntyre, P . ;Working Party of the Australian and New Zealand College of Anaesthetists :Acute Pain Management: Scientific Evidence, ,2nd Ed. ,Australian and New Zealand College of Anaesthetists. ,Melbourne, Australia. ,2005. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11.

    Awad, IT and F Chung. :Factors affecting recovery and discharge following ambulatory surgery. .Can J Anaesth 53::858. ,2006. .

  • 12.

    Bourne, MH . :Analgesics for orthopedic postoperative pain. .Am J Orthop 33::128. ,2004. .

  • 13.

    Shang, AB and TJ Gan. :Optimising postoperative pain management in the ambulatory patient. .Drugs 63::855. ,2003. .

  • 14.

    Chevlen, E . :Opioids: a review. .Curr Pain Headache Rep 7::15. ,2003. .

  • 15.

    Christo, PJ, TS Grabow, and SN Raja. :Opioid effectiveness, addiction, and depression in chronic pain. .Adv Psychosom Med 25::123. ,2004. .

  • 16.

    Schug, SA, D Zech, and S Grond. :Adverse effects of systemic opioid analgesics. .Drug Saf 7::200. ,1992. .

  • 17.

    Tzschentke, TM, J De Vry, R Terlinden, et al. :Tapentadol HCl. .Drugs Future 31::1053. ,2006. .

  • 18.

    Daniels, S, E Casson, JU Stegmann, et al. :A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. .Curr Med Res Opin 25::1551. ,2009. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    Daniels, SE, D Upmalis, A Okamoto, et al. :A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. .Curr Med Res Opin 25::765. ,2009. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20.

    Hale, M, D Upmalis, A Okamoto, et al. :Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study. .Curr Med Res Opin 25::1095. ,2009. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21.

    Hartrick, C, I Van Hove, JU Stegmann, et al. :Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. .Clin Ther 31::260. ,2009. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22.

    Stegmann, JU, H Weber, A Steup, et al. :The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery. .Curr Med Res Opin 24::3185. ,2008. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23.

    Tzschentke, TM, T Christoph, B Kögel, et al. :(−)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): a novel μ-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. .J Pharmacol Exp Ther 323::265. ,2007. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24.

    Ford, LB . :Soft-tissue bunionectomy in podiatric surgery. .Clin Podiatr Med Surg 8::63. ,1991. .

  • 25.

    Dalton, JA and R Youngblood. :Clinical application of the World Health Organization analgesic ladder. .J Intraven Nurs 23::118. ,2000. .

  • 26.

    Millen, S and C Sheikh. :Anaesthesia and surgical pain relief: managing post-operative pain. .Hosp Pharm 10::442. ,2003. .

  • 27.

    Carr, DB and LC Goudas. :Acute pain. .Lancet 353::2051. ,1999. .

  • 28.

    Power, I and S Barratt. :Analgesic agents for the postoperative period: nonopioids. .Surg Clin North Am 79::275. ,1999. .

  • 29.

    Langford, RM . :Pain management today: what have we learned? Clin Rheumatol 25( suppl 7:):2. ,2006. .

  • 30.

    Gimbel, JS, A Brugger, W Zhao, et al. :Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. .Clin Ther 23::228. ,2001. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31.

    Reuben, SS, EF Ekman, and D Charron. :Evaluating the analgesic efficacy of administering celecoxib as a component of multimodal analgesia for outpatient anterior cruciate ligament reconstruction surgery. .Anesth Analg 105::222. ,2007. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32.

    McGettigan, P and D Henry. :Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. .JAMA 296::1633. ,2006. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 33.

    Austrup, ML and G Korean. :Analgesic agents for the postoperative period: opioids. .Surg Clin North Am 79::253. ,1999. .

  • 34.

    Stephens, J, B Laskin, C Pashos, et al. :The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors. .Rheumatology (Oxford) 42( suppl 3:):iii40. ,2003. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 35.

    Cherny, NI . :Opioid analgesics: comparative features and prescribing guidelines. .Drugs 51::713. ,1996. .

  • 36.

    Smith, RG . :A review of opioid analgesics frequently prescribed by podiatric physicians. .JAPMA 96::367. ,2006. .

  • 37.

    Thipphawong, JB, N Babul, RJ Morishige, et al. :Analgesic efficacy of inhaled morphine in patients after bunionectomy surgery. .Anesthesiology 99::693. ,2003. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 38.

    Christo, PJ . :Opioid effectiveness and side effects in chronic pain. .Anesthesiol Clin North Am 21::699. ,2003. .

  • 39.

    Benyamin, R, AM Trescot, S Datta, et al. :Opioid complications and side effects. .Pain Physician 11::S105. ,2008. .

  • 40.

    Kieffer, BL . :Opioids: first lessons from knockout mice. .Trends Pharmacol Sci 20::19. ,1999. .

  • 41.

    Matthes, HW, R Maldonado, F Simonin, et al. :Loss of morphine-induced analgesia, reward effect and withdrawal symptoms in mice lacking the μ-opioid-receptor gene. .Nature 383::819. ,1996. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42.

    Kovac, AL . :Prevention and treatment of postoperative nausea and vomiting. .Drugs 59::213. ,2000. .

  • 43.

    Gan, TJ, T Meyer, CC Apfel, et al. :Consensus guidelines for managing postoperative nausea and vomiting. .Anesth Analg 97::62. ,2003. .

  • 44.

    Philip, BK, PR Reese, and SP Burch. :The economic impact of opioids on postoperative pain management. .J Clin Anesth 14::354. ,2002. .

  • 45.

    Gan, TJ . :Postoperative nausea and vomiting: can it be eliminated? JAMA 287::1233. ,2002. .

  • 46.

    Gan, TJ . :Risk factors for postoperative nausea and vomiting. .Anesth Analg 102.:1884. ,2006. .

  • 47.

    Herndon, CM, KC Jackson II, and PA Hallin. :Management of opioid-induced gastrointestinal effects in patients receiving palliative care. .Pharmacotherapy 22::240. ,2002. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 48.

    Habib, AS and TJ Gan. :Evidence-based management of postoperative nausea and vomiting: a review. .Can J Anaesth 51::326. ,2004. .

  • 49.

    Mendoza, TR, C Chen, A Brugger, et al. :Lessons learned from a multiple-dose post-operative analgesic trial. .Pain 109::103. ,2004. .

Clinical Efficacy and Safety of Tapentadol Immediate Release in the Postoperative Setting

Stephen E. Daniels Premier Research Group, Austin, TX.

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Michael Golf Premier Research Group, Austin, TX.

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The appropriate treatment for postoperative pain remains a common dilemma for podiatric surgeons and patients undergoing surgery of the foot and ankle. The treatment of moderate to severe acute pain typically relies heavily on the use of opioid analgesics, such as hydrocodone and oxycodone, which are often associated with adverse effects, including nausea and vomiting. These adverse effects may have a negative impact on postoperative outcomes and reduce patient compliance with analgesic therapy. Tapentadol is a novel, centrally acting analgesic with two mechanisms of action—μ-opioid receptor agonism and norepinephrine reuptake inhibition—in a single molecule. Tapentadol immediate release has been evaluated in a series of clinical trials in patients with postoperative pain after bunionectomy. The results of these studies demonstrate that tapentadol immediate release is associated with an improved gastrointestinal tolerability profile relative to oxycodone immediate release at doses providing comparable analgesia. Therefore, tapentadol immediate release may offer an improved analgesic option for the relief of postoperative pain after podiatric surgery. (J Am Podiatr Med Assoc 102(2): 139–148, 2012)

Corresponding author: Stephen E. Daniels, DO, Executive Medical Director, Clinical Research Centers, Premier Research Group Ltd, 3200 Red River, Suite 300, Austin, TX 78705. (E-mail: stephen.daniels@premier-research.com)
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