Analgesic efficacy and safety of a novel injectable formulation of diclofenac compared with intravenous ketorolac and placebo after orthopedic surgery: A multicenter, randomized, double-blinded, multiple-dose trial

Clinical Journal of Pain

Volumn 29, Issue 8, 2013, Pages 655-663

  Daniels, Stephen ^a   Melson, Timothy ^b   Hamilton, Douglas A ^c   Lang, Eric ^c   Carr, Daniel B ^c,d  

^a Premier Clinical Research Centers   (United States)

^b Helen Keller Hospital   (United States)

^c Javelin Pharmaceuticals Inc   (United States)

^d TUFTS MEDICAL CENTER   (United States)

Author keywords

Diclofenac; Dyloject; NSAID; Postoperative pain

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; DICLOFENAC; KETOROLAC; MORPHINE; PLACEBO;

ADULT; AGED; ANALGESIA; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORTHOPEDIC SURGERY; POSTOPERATIVE PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; COHORT STUDIES; DICLOFENAC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; KETOROLAC; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84880576889     PISSN: 07498047     EISSN: 15365409     Source Type: Journal    
DOI: 10.1097/AJP.0b013e318270f957     Document Type: Article

References (28)

1. Ashburn MA, Caplan RA, Carr DB, et al. 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. 2004;100:1573-1581.
2. Macintyre PE, Schug SA, Scott DA, et al. Acute Pain Management: Scientific Evidence. 3rd ed. Melbourne, Australia: Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine; 2010.
3. White PF, Kehlet H, Neal JM, et al. The role of the anesthesiologist in fast-track surgery: from multimodal analgesia to perioperative medical care. Anesth Analg. 2007;104: 1380-1396.
4. Liu SS, Wu CL. Effect of postoperative analgesia on major postoperative complications: a systematic update of the evidence. Anesth Analg. 2007;104:689-702.
5. Sinatra RS, Jahr JS, Reynolds LW, et al. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102: 822-831.
6. Kroll PB, Meadows L, Rock A, et al. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011;11:23-32.
7. Southworth S, Peters J, Rock A, et al. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800mg every 6 hours in the management of postoperative pain. Clin Ther. 2009;31:1922-1935.
8. Bauer KA, Gerson W, Wright CT, et al. Platelet function following administration of a novel formulation of intravenous diclofenac sodium versus active comparators: a randomized, single dose, crossover study in healthy male volunteers. J Clin Anesth. 2010;22:510-518.
9. Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patientcontrolled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005;103:1296-1304.
10. Ketorolac tromethamine. Physicians Desk Reference monograph. Available at: http://www.PDR.net. Accessed May 11, 2011.
11. Todd PA, Sorkin EM. Diclofenac sodium: a reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1988;35:244-285.
12. Barden J, Edwards J, Moore RA, et al. Single dose oral diclofenac for postoperative pain. Cochrane Database Syst Rev. 2004;CD004768.
13. Gan TJ. Diclofenac: an update on its mechanism of action and safety profile. Curr Med Res Opin. 2010;26:1715-1731.
14. Loftsson T, Hreinsdottir D, Masson M. Evaluation of cyclodextrin solubilization of drugs. Int J Pharm. 2005;302:18-28.
15. Christensen K, Daniels S, Bandy D, et al. A double-blind placebo-controlled comparison of a novel formulation of intravenous diclofenac and ketorolac for postoperative third molar extraction pain. Anesth Prog. 2011;58:73-81.
16. Gan TJ, Bauer K, Gerson W, et al. A novel parenteral NSAID in acute pain management. Acute Pain. 2008;10:165-166.
17. Madanick RD, O'Loughlin CJ, Barkin JS. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Dig Dis Sci. 2005;50:879-881.
18. Aubrun F, Marmion F. The elderly patient and postoperative pain treatment. Best Pract Res Clin Anaesthesiol. 2007;21: 109-127.
19. Richy F, Bruyere O, Ethgen O, et al. Time dependent risk of gastrointestinal complications induced by non-steroidal antiinflammatory drug use: a consensus statement using a metaanalytic approach. Ann Rheum Dis. 2004;63:759-766.
20. Frampton C, Quinlan J. Evidence for the use of non-steroidal anti-inflammatory drugs for acute pain in the post anaesthesia care unit. J Perioper Pract. 2009;19:418-423.
21. Vonkeman HE, van de Laar MA. Nonsteroidal anti-inflammatory drugs: adverse effects and their prevention. Semin Arthritis Rheum. 2010;39:294-312.
22. Gan TJ, Daniels SE, Singla N, et al. Novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter double-blind, randomized, multiple dose study. Anesth Analg. 2012. In press.
23. Kheterpal S, Tremper KK, Heung M, et al. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009;110:505-515.
24. Alexander R, El-Moalem HE, Gan TJ. Comparison of the morphine-sparing effects of diclofenac sodium and ketorolac tromethamine after major orthopedic surgery. J Clin Anesth. 2002;14:187-192.
25. Silvanto M, Lappi M, Rosenberg PH. Comparison of the opioidsparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty. Acta Anaesthesiol Scand. 2002;46:322-328.
26. Laitinen J, Nuutinen L, Kiiskila EL, et al. Comparison of intravenous diclofenac, indomethacin and oxycodone as postoperative analgesics in patients undergoing knee surgery. Eur J Anaesthesiol. 1992;9:29-34.
27. Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008;248:189-198.
28. Andersen LO, Gaarn-Larsen L, Kristensen BB, et al. Subacute pain and function after fast-track hip and knee arthroplasty. Anaesthesia. 2009;64:508-513.