COMPARATIVE EFFICACY AND SAFETY OF ROFECOXIB VERSUS DICLOFENAC IN PERIOPERATIVE PAIN MANAGEMENT FOR GYNECOLOGICAL SURGERIES
DOI:
https://doi.org/10.48047/j9d2v158Keywords:
Rofecoxib, Diclofenac, Perioperative Pain Management, Gynecological Surgeries, Platelet AggregationAbstract
Non-steroidal anti-inflammatory drugs (NSAIDs) are the most widely used drugs in pain management though they have negative effects that reduce their application in the perioperative period, of which non-selective cyclooxygenase (COX) inhibitors are the worst offenders. The selective COX-2 inhibitors, such as rofecoxib are regarded as safer medications, as they have little effect on the activity of platelets and produce less gastrointestinal disorders. The purpose of the study was to compare the problematic of a single 50 mg dose of rofecoxib against rofecoxib and three doses of 50 mg each of diclofenac on the effects of the drugs on the platelet functions, blood loss as well as pain control during the gynecological operations. An active-comparator clinical trial (random/double-blind/double-dummy) was performed on 75 patients who received vaginal hysterectomy or breast operation. The trial evaluated platelet aggregation, blood loss during the procedure, and hemoglobin changes postoperatively and the requirement of extra pain killers or anti-vomiting drugs. Conclusions were that rofecoxib considerably decreased platelet aggregations (P = 0.02), intraoperative blood shed (P = 0.01) and hemoglobin shedding (P = 0.01) as compared to diclofenac. Also, rofecoxib controlled pain in a similar proportion to that of three doses of Diclofenac and hence fewer anti-emety drugs were needed (P = 0.03). These results indicate that rofecoxib is superior in its hemostatic effect, lowers oxidative stress, it has a better side-effect profile than diclofenac. Briefly, despite the comparable results in terms of analgesic effect, the potential benefit of rofecoxib to limit bleeding, postoperative complications and a minimal number of gastrointestinal adverse effects renders it to be a viable alternative to non-selective NSAIDs in perioperative pain management. Nevertheless, subsequent investigations are required to assess the positive correlation between the long term cardiovascular safety of COX-2 inhibitors and their extensive application in the high-risk surgical patients.
Downloads
References
Bamber, M. J., Tweedie, I. E., & Breeze, C. (1997). Premedication with controlled release diclofenac sodium reduces post-operative pain after minor gynaecological surgery. Eur J Anaesthesiol, 14, 421–427.
Perttunen, K., Nilsson, E., & Kalso, E. (1999). I.V. diclofenac and ketorolac for pain after thoracoscopic surgery. Br J Anaesth, 82, 221–227.
Lee, A., Cooper, M. C., & Craig, J. C. (2001). Effects of nonsteroidal anti-inflammatory drugs on post-operative renal function in normal adults (Cochrane Review). Cochrane Database Syst Rev, 2.
Gabbott, D. A., Cohen, A. M., & Mayor, A. H. (1997). The influence of timing of ketorolac administration on post-operative analgesic requirements following total abdominal hysterectomy. Eur J Anaesthesiol, 14, 610–615.
Strom, B. L., Berlin, J. A., & Kinman, J. L. (1996). Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA, 275, 376–382.
Leese, P. T., Hubbard, R. C., & Karim, A. (2000). Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: a randomized, controlled trial. J Clin Pharmacol, 40, 124–132.
Bombardier, C., Laine, L., Reicin, A., et al. (2000). Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med, 343, 1520–1528.
Mehlisch, D. R., & Fulmer, R. I. (1997). A crossover comparison of bromfenac sodium, naproxen sodium, and placebo for relief of pain from primary dysmenorrhea. J Womens Health, 6, 83–92.
Raineri-Gerber, I., von Felten, A. (1991). Inhibition of thrombocyte function by non-steroidal anti-rheumatic agents: a comparative study between diclofenac, acemetacin, mefenamic acid and ibuprofen. Schweiz Med Wochenschr, 121, 783–787.
Camenzind, V., Bombeli, T., Seifert, B., et al. (2000). Citrate storage affects thrombelastograph analysis. Anesthesiology, 92, 1242–1249.
Laisalmi, M., Teppo, A. M., Koivusalo, A. M., et al. (2001). The effect of ketorolac and sevoflurane anesthesia on renal glomerular and tubular function. Anesth Analg, 93, 1210–1213.
Riendeau, D., Charleson, S., Cromlish, W., et al. (1997). Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmacol, 75, 1088–1095.
Chan, C. C., Boyce, S., Brideau, C., et al. (1999). Rofecoxib [Vioxx, MK-0966; 4-(4′-methylsulfonylphenyl)-3-phenyl-2-(5H)-furanone]: a potent and orally active cyclooxygenase-2 inhibitor. Pharmacological and biochemical profiles. J Pharmacol Exp Ther, 290, 551–560.
Leese, P. T., Talwalker, S., Kent, J. D., et al. (2002). Valdecoxib does not impair platelet function. Am J Emerg Med, 20, 275–281.
VanHecken, A., Schwartz, J. I., Depre, M., et al. (2000). Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol, 40, 1109–1120.
Merck & Co. Inc. (1998). Vioxx™ prescribing information. Whitehouse Station: Merck & Co., New Jersey.
Kendall, M. J., Thornhill, D. P., & Willis, J. V. (1979). Factors affecting the pharmacokinetics of diclofenac sodium (Voltarol). Rheumatol Rehabil, 38, 38–46.
Yuan, C. S., Foss, J. F., O'Connor, M., et al. (1998). Effects of low-dose morphine on gastric emptying in healthy volunteers. J Clin Pharmacol, 38, 1017–1020.
Reinhart, D. J., Latson, T. W., Whitten, C. W., et al. (1993). Influence of ketorolac tromethamine on clot elastic strength in humans as assessed by thromboelastography. J Clin Anesth, 5, 216–220.
Mukherjee, D., Nissen, S. E., & Topol, E. J. (2001). Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA, 286, 954–959.
Reicin, A. S., Shapiro, D., Sperling, R. S., et al. (2002). Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone). Am J Cardiol, 89, 204–209.
Schmidt, A., Bjorkman, S., & Akeson, J. (2001). Preoperative rectal diclofenac versus paracetamol for tonsillectomy: effects on pain and blood loss. Acta Anaesthesiol Scand, 45, 48–52.
Catella-Lawson, F., McAdam, B., Morrison, B. W., et al. (1999). Effects of specific inhibition of cyclooxygenase-2 on sodium balance, hemodynamics, and vasoactive eicosanoids. J Pharmacol Exp Ther, 289, 735–741.
Reuben, S. S., & Connelly, N. R. (2000). Postoperative analgesic effects of celecoxib or rofecoxib after spinal fusion surgery. Anesth Analg, 91, 1221–1225.
Reuben, S. S., Fingeroth, R., & Krushell, R. (2002). Evaluation of the safety and efficacy of the perioperative administration of rofecoxib for total knee arthroplasty. J Arthroplasty, 17, 26–31.
Watcha, M. F., Issioui, T., & Klein, K. W. (2003). Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg, 96, 987–994.
Fredman, B., Jedeikin, R., & Olsfanger, D. (1993). The opioid-sparing effect of diclofenac sodium in outpatient extracorporeal shock wave lithotripsy (ESWL). J Clin Anesth, 5, 141–144.
Rautoma, P., Santanen, U., & Avela, R. (2000). Diclofenac premedication but not intra-articular ropivacaine alleviates pain following day-case knee arthroscopy. Can J Anaesth, 47, 220–224.
Niccoli, L., Bellino, S., & Cantini, F. (2002). Renal tolerability of three commonly employed non-steroidal anti-inflammatory drugs in elderly patients with osteoarthritis. Clin Exp Rheumatol, 20, 201–207.
Ahmad, S. R., Kortepeter, C., & Brinker, A. (2002). Renal failure associated with the use of celecoxib and rofecoxib. Drug Saf, 25, 537–544.
Ramsay, M. A., Savege, T. M., & Simpson, B. R. (1974). Controlled sedation with alphaxalone-alphadolone. Br Med J, 2, 656–659.
Downloads
Published
Issue
Section
License
Copyright (c) 2022 Dr. Gawtham D, Dr. Kumara Raghavendra Varma (Author)
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
