Dyloject®, a novel injectable diclofenac solubilised with cyclodextrin: Reduced incidence of thrombophlebitis compared to injectable diclofenac solubilised with polyethylene glycol and benzyl alcohol

Acute Pain

Volumn 11, Issue 1, 2009, Pages 15-21

  Colucci, Robert D ^a   Wright IV, Curtis ^a   Mermelstein, Fred H ^a   Gawarecki, Daniel G ^a   Carr, Daniel B ^a  

^a Javelin Pharmaceuticals Inc   (United States)

Author keywords

Anti inflammatory agents; Diclofenac; Injections; Intravenous; Non steroidal; Pain; Postoperative; Thrombophlebitis

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; BENZYL ALCOHOL; DICLOFENAC; DYLOJECT; MACROGOL; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BOLUS INJECTION; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG FORMULATION; DRUG SAFETY; FEMALE; HUMAN; INCIDENCE; MALE; PRIORITY JOURNAL; THROMBOPHLEBITIS;

EID: 63249123225     PISSN: 13660071     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.acpain.2008.11.001     Document Type: Article

References (50)

1. Carr D.B., Jacox A.K., Chapman C.R., Ferrell B.R., Fields H.L., Heidrich III G., et al. Acute pain management in infants, children and adolescents: operative and medical procedures (1992), Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health & Human Services, Rockville, MD
2. Ashburn M.A., Caplan R.A., Carr D.B., Connis R.T., Ginsberg B., Green C.R., et al. Practice guidelines for acute pain management in the perioperative setting. An updated report by the American Society of Anesthesiologists Task Force on Pain Management. Anesthesiology 100 (2004) 1573-1581
3. McIntyre P., and (on behalf of the Working Party). Acute pain management: scientific evidence. second edition (2005), Australian and New Zealand College of Anaesthetists, Melbourne
4. Cepeda M.S., Miranda N., Diaz A., Silva C., Morales O., and Carr D.B. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double blind trial. Anesthesiology 103 (2005) 1225-1232
5. Elia N., Lysakowski C., and Tramer M.R. Does multimodal analgesia with acetaminophen, nonsteroidal anti-inflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analysis of randomized trials. Anesthesiology 103 (2005) 1296-1304
6. Marret E., Kurdi O., Zufferey P., and Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects. Meta-analysis of randomized controlled trials. Anesthesiology 102 (2005) 1249-1260
7. Maier R., Menasse R., Riesterer L., Pericin C., Ruegg M., and Ziel R. The pharmacology of diclofenac sodium (Voltarol). Rheumatol Rehabil Suppl. 2 (1979) 11-21
8. Mitchell J.A., Akarasereenont P., Thiemermann C., Flower R.J., and Vane J.R. Selectivity of nonsteroidal antiinflammatory drugs as inhibitors of constitutive and inducible cyclooxygenase. Proc Natl Acad Sci USA 90 (1994) 11693-11697
9. Jenkins JK, Seligman PJ. Memorandum: analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. United States Food and Drug Administration Center for Drug Evaluation and Research, April 6, 2005. www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf [accessed 07/31/08].
10. European Medicines Agency. European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs. London, 24 October 2006, Doc. Ref. EMEA/413136/2006.
11. Barden J., Edwards J., Moore R.A., and McQuay H.J. Single dose oral diclofenac for postoperative pain. Cochrane Database Syst Rev 2 (2004) Art. No.: CD004768. doi:10.1002/14651858.CD004768
12. Novartis Pharmaceuticals UK Ltd. Voltarol ampoules. Summary of product characteristics; 2004 http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=1339 [accessed 07/31/08].
13. Campbell W.I., and Watters C.H. Venous sequelae following i.v. administration of diclofenac. Br J Anaesth 62 (1989) 545-547
14. Javelin Pharmaceuticals. Dyloject summary of product characteristics; 2007.
15. ® for postoperative dental pain. Reg Anesth Pain Med 32 (2007) 303-310
16. Christensen K., Daniels S., Bandy D., Ernst C.C., Hamilton D.A., Mermelstein F.H., et al. Dyloject™, a novel injectable diclofenac: efficacy of unexpectedly low doses and faster onset than ketorolac. Eur J Pain 10 S1 (2006) S168 [abstract 643]
17. Stevens D.A. Itraconazole in cyclodextrin solution. Pharmacotherapy 19 (1999) 603-611
18. Baker M.T., and Naguib M. Propofol: the challenges of formulation. Anesthesiology 103 (2005) 860-876
19. Dinley R.J. Venous reactions related to indwelling plastic cannulae: a prospective clinical trial. Curr Med Res Opin 3 (1976) 607-611
20. Chan I.S.F., and Zhang Z. Test-based exact confidence intervals for the difference of two binomial proportions. Biometrics 55 (1999) 1202-1209
21. Claeys M.A., Camu F., and Maes V. Prophylactic diclofenac infusions in major orthopedic surgery: effects on analgesia and acute phase proteins. Acta Anaesth Scand 36 (1992) 270-275
22. Tigerstedt I., Janhunen L., and Tammisto T. Efficacy of diclofenac in a single prophylactic dose in postoperative pain. Ann Clin Res 19 (1987) 18-22
23. Rockemann M.G., Seeling W., Bischof C., Borstinghaus D., Steffen P., and Georgieff M. Prophylactic use of epidural mepivacaine/morphine, systemic diclofenac, and metamizole reduces postoperative morphine consumption after major abdominal surgery. Anesthesiology 84 (1996) 1027-1034
24. Jakobsson J., Rane K., and Davidson S. Intramuscular NSAIDS reduce post-operative pain after minor outpatient anaesthesia. Eur J Anaesth 13 (1996) 67-71
25. Hyrkas T., Ylipaavalniemi P., Oikarinen V.J., and Hampf G. Postoperative pain prevention by a single-dose formulation of diclofenac producing a steady plasma concentration. J Oral Maxillofac Surg 50 (1992) 124-127
26. Hyrkas T., Ylipaavalniemi P., Oikarinen V.J., and Paakkari I. Preoperative intravenous diclofenac for postoperative pain prevention in outpatients. Br J Oral Maxillofac Surg 31 (1993) 351-354
27. Hovorka J., Kallela H., and Korttila K. Effect of intravenous diclofenac on pain and recovery profile after day-case laparoscopy. Eur J Anaesth 10 (1993) 105-108
28. Ryhanen P., Adamski J., Puhakka K., Leppaluoto J., Vuolteenaho O., and Ryhanen J. Postoperative pain relief in children. A comparison between caudal bupivacaine and intramuscular diclofenac sodium. Anaesthesia 49 (1994) 57-61
29. Anderson S.K., and al Shaikh B.A. Diclofenac in combination with opiate infusion after joint replacement surgery. Anaesth Intensive Care 19 (1991) 535-538
30. Gürkan Y., Kiliçkan L., Buluc L., Müezzinoglu S., and Toker K. Effects of diclofenac and intra-articular morphine/bupivacaine on postarthroscopic pain control. Minerva Anestesiol 65 (1999) 741-745
31. Hynes D., McCarroll M., and Hiesse-Provost O. Analgesic efficacy of parenteral paracetamol (propacetamol) and diclofenac in post-operative orthopaedic pain. Acta Anaesth Scand 50 (2006) 374-381
32. Alexander R., El-Moalem H.E., and Gan T.J. Comparison of the morphine-sparing effects of diclofenac sodium and ketorolac tromethamine after major orthopedic surgery. J Clin Anesth 14 (2002) 187-192
33. Silvanto M., Lappi M., and Rosenberg P.H. Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for three days after knee arthroplasty. Acta Anaesth Scand 46 (2002) 322-328
34. Hodsman N.B., Burns J., Blyth A., Kenny G.N., McArdle C.S., and Rotman H. The morphine sparing effects of diclofenac sodium following abdominal surgery. Anaesthesia 42 (1987) 1005-1008
35. Moffat A.C., Kenny G.N., and Prentice J.W. Postoperative nefopam and diclofenac. Evaluation of their morphine-sparing effect after upper abdominal surgery. Anaesthesia 45 (1990) 302-305
36. Campbell W.I., Kendrick R., and Patterson C. Intravenous diclofenac sodium. Does its administration before operation suppress postoperative pain?. Anaesthesia 45 (1990) 763-766
37. Campbell W.I., and Kendrick R.W. Postoperative dental pain-a comparative study of anti-inflammatory and analgesic agents. Ulster Med J 60 (1991) 39-43
38. Seymour R.A., Moore U., Hawkesford J., Coulthard P., Jackson-Leech D., Thomas D., et al. An investigation into the efficacy of intravenous diclofenac in post-operative dental pain. Eur J Clin Pharm 56 (2000) 447-452
39. Walton G.M., Rood J.P., Snowdon A.T., and Rickwood D. Ketorolac and diclofenac for postoperative pain relief following oral surgery. Br J Oral Maxillofac Surg 31 (1993) 158-160
40. Al-Waili N.S. Efficacy and safety of repeated postoperative administration of intramuscular diclofenac sodium in the treatment of post-cesarean section pain: a double-blind study. Arch Med Res 32 (2001) 148-154
41. Buggy D.J., Wall C., and Carton E.G. Preoperative or postoperative diclofenac for laparoscopic tubal ligation. Br J Anaesth 73 (1994) 767-770
42. Fredman B., Olsfanger D., and Jedeikin R. A comparative study of ketorolac and diclofenac on post-laparoscopic cholecystectomy pain. Eur J Anaesth 12 (1995) 501-504
43. Wilson Y.G., Rhodes M., Ahmed R., Daugherty M., Cawthorn S.J., and Armstrong C.P. Intramuscular diclofenac sodium for postoperative analgesia after laparoscopic cholecystectomy: a randomised, controlled trial. Surg Laparosc Endosc 4 (1994) 340-344
44. Cohen E., Hafner R., Rotenberg Z., Fadilla M., and Garty M. Comparison of ketorolac and diclofenac in the treatment of renal colic. Eur J Clin Pharm 54 (1998) 455-458
45. Vignoni A., Fierro A., Moreschini G., Cau M., Agostino A., Daniele E., et al. Diclofenac sodium in ureteral colic: a double-blind comparison trial with placebo. J Inter Med Res 11 (1983) 303-307
46. Doenicke A., Nebauer A.E., Hoernecke R., Mayer M., and Roizen M.F. Osmolalities of propylene glycol-containing drug formulations for parenteral use. Should propylene glycol be used as a solvent?. Anesth Analg 75 (1992) 431-435
47. In: Rowe R.C., Sheskey P.J., Weller, and PJ (Eds). Handbook of pharmaceutical excipients (2003), American Pharmaceutical Association, Washington, DC
48. Wallerstein K. A cost minimization analysis of IV bolus versus IV infusion diclofenac in post-operative pain. International Society for Pharmacoeconomic and Outcomes Research (ISPOR). Proceedings of the 10th Annual European Congress. Dublin, October 20-23 (2007) [Abstract PPN2]
49. National Patient Safety Agency. www.npsa.nhs.uk [accessed 07/31/08].
50. Clopper C.J., and Pearson E.S. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26 (1934) 404-413