Analysis of clinical efficacy and safety of intravenous use of diclofenac for the prevention of postoperative pain: current status and strategic aspect

Authors

DOI:

https://doi.org/10.15587/2519-4852.2020.197338

Keywords:

diclofenac, postoperative pain, opioid-saving effect, intravenous injection

Abstract

The aim of the work is to analyze and systematize the literature data regarding the current state and strategic aspect of intravenous use of diclofenac for the prevention of postoperative pain, namely clinical efficacy and safety.

Materials and methods. Studies were conducted using databases on the Internet: PubMed; Food and Drug Administration, European Medicines Agency. It has used retrospective, logical, research methods, content analysis.

Results. Conducted clinical data analysis indicates that diclofenac sodium, when administered intravenously, has an opioid-saving effect, is effective in patients experiencing acute postoperative pain, or as part of a multimodal analgesic strategy to achieve perioperative pain control. This increases the possibility of relief of pain and promotes accelerated rehabilitation after surgery, reduces the need for opiates. The incidence of side effects with intravenous diclofenac was similar to that seen with other treatments. New opportunities of the strategic aspect of intravenous use of diclofenac is related to the use of Dyloject, Hospira Inc., USA, which has improved solubility, shorter administration time than infusion. The incidence of thrombophlebitis on treatment with Dyloject was less pronounced compared to Voltarol.

Conclusions. Thus, the experience of clinical intravenous use of diclofenac sodium for the prevention of postoperative pain has confirmed its efficacy, favorable safety profile and the ability to reduce the need for opiates. The promising strategic aspect is the creation of domestic diclofenac sodium preparations for intravenous administration, which have improved solubility, shorter administration time than infusions and have no additional safety risk

Author Biography

Elena Litvinova, National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Associate Professor

Department of Management and Economics of Enterprise

References

  1. Walker, C., Biasucci, L. M. (2017). Cardiovascular safety of non-steroidal anti-inflammatory drugs revisited. Postgraduate Medicine, 130 (1), 55–71. doi: http://doi.org/10.1080/00325481.2018.1412799
  2. Altman, R., Bosch, B., Brune, K., Patrignani, P., Young, C. (2015). Advances in NSAID Development: Evolution of Diclofenac Products Using Pharmaceutical Technology. Drugs, 75 (8), 859–877. doi: http://doi.org/10.1007/s40265-015-0392-z
  3. Chou, R., Gordon, D. B., de Leon-Casasola, O. A., Rosenberg, J. M., Bickler, S. et al. (2016). Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. The Journal of Pain, 17 (2), 131–157. doi: http://doi.org/10.1016/j.jpain.2015.12.008
  4. Pitchon, D. N., Dayan, A. C., Schwenk, E. S., Baratta, J. L., Viscusi, E. R. (2018). Updates on Multimodal Analgesia for Orthopedic Surgery. Anesthesiology Clinics, 36 (3), 361–373. doi: http://doi.org/10.1016/j.anclin.2018.05.001
  5. Yoshida, M., Shimizu, Y., Yoshida, K., Mukai, A., Doi, M., Irifune, M. (2018). Effective Postoperative Analgesia Using Intravenous Flurbiprofen and Acetaminophen. Journal of Oral and Maxillofacial Surgery, 76 (9), 1869–1872. doi: http://doi.org/10.1016/j.joms.2018.03.031
  6. Elia, N., Lysakowski, C., Tramèr, M. R. (2005). Does Multimodal Analgesia with Acetaminophen, Nonsteroidal Antiinflammatory Drugs, or Selective Cyclooxygenase-2 Inhibitors and Patient-controlled Analgesia Morphine Offer Advantages over Morphine Alone? Anesthesiology, 103 (6), 1296–1304. doi: http://doi.org/10.1097/00000542-200512000-00025
  7. Marret, E., Kurdi, O., Zufferey, P., Bonnet, F. (2005). Effects of Nonsteroidal Antiinflammatory Drugs on Patient-controlled Analgesia Morphine Side Effects. Anesthesiology, 102 (6), 1249–1260. doi: http://doi.org/10.1097/00000542-200506000-00027
  8. British National Formulary 76 (2018). London: Pharmaceutical Press, 1640. doi: http://doi.org/10.18578/bnf.147942626
  9. Hoy, S. M. (2016). Diclofenac Sodium Bolus Injection (DylojectTM): A Review in Acute Pain Management. Drugs, 76 (12), 1213–1220. doi: http://doi.org/10.1007/s40265-016-0619-7
  10. George, N. E., Gurk-Turner, C., Castrodad, I. M. D., Etcheson, J. I., Mohamed, N. S., Gwam, C. U. et. al. (2019). Adjunctive Intravenous Diclofenac Decreases Opioid Consumption and Increases Satisfaction in the Primary Total Hip Arthroplasty Population. Surgical Technology International, 34, 456–461.
  11. Gan, T., Singla, N., Daniels, S. E., Hamilton, D., Lacouture, P., Reyes, C., Carr, D. (2016). Postoperative opioid sparing with injectable hydroxypropyl-β-cyclodextrin-diclofenac: pooled analysis of data from two Phase III clinical trials. Journal of Pain Research, 10, 15–29. doi: http://doi.org/10.2147/jpr.s106578
  12. Daniels, S., Melson, T., Hamilton, D. A., Lang, E., Carr, D. B. (2013). Analgesic Efficacy and Safety of a Novel Injectable Formulation of Diclofenac Compared With Intravenous Ketorolac and Placebo After Orthopedic Surgery. The Clinical Journal of Pain, 29 (8), 655–663. doi: http://doi.org/10.1097/ajp.0b013e318270f957
  13. Jenifer, M., Radhesh, H. (2019). A study on efficacy of intravenous diclofenac and ketorolacon post laparoscopic cholecystectomy pains. International Journal of Science and Research, 8 (11), 217–221.
  14. Binay, T., Mukti, D., Krishna, K., Bishal, S. (2018). Intravenous Diclofenac vs. Tramadol infusion for Post-operative Pain Management: A Randomized Trial. Nepalese Journal of Cancer, 2 (1), 38–42. doi: http://doi.org/10.3126/njc.v2i1.25649
  15. Agrawal, S. A., Nikhate, S. D., Thakur, M. M., Bal, H. (2019). A study of comparison of efficacy and side effects of intravenous paracetamol and intravenous diclofenac as a postoperative analgesic. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 8 (9), 3684–3688. doi: http://doi.org/10.18203/2320-1770.ijrcog20193798
  16. Shah, U., Dudhwala, K., Vakil, M. (2019). Prospective, double-blind randomized study of comparison of analgesic efficacy of parenteral paracetamol and diclofenac for postoperative pain relief. Journal of Anaesthesiology Clinical Pharmacology, 35 (2), 188–191. doi: http://doi.org/10.4103/joacp.joacp_384_16
  17. Alexander, R., El-Moalem, H. E., Gan, T. J. (2002). Comparison of the morphine-sparing effects of diclofenac sodium and ketorolac tromethamine after major orthopedic surgery. Journal of Clinical Anesthesia, 14 (3), 187–192. doi: http://doi.org/10.1016/s0952-8180(01)00382-8
  18. Silvanto, M., Lappi, M., Rosenberg, P. H. (2002). Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty. Acta Anaesthesiologica Scandinavica, 46 (3), 322–328. doi: http://doi.org/10.1034/j.1399-6576.2002.t01-1-460316.x
  19. Howard, M. L., Isaacs, A. N., Nisly, S. A. (2016). Continuous Infusion Nonsteroidal Anti-Inflammatory Drugs for Perioperative Pain Management. Journal of Pharmacy Practice, 31 (1), 66–81. doi: http://doi.org/10.1177/0897190016665539
  20. Nze, P. U. N., Onyekwulu, F. (2006) Intraoperative Diclofenac for Post-Adenoidectomy Analgesia in Small Children. Nigerian Journal of Clinical Practice, 9 (2), 102–104.
  21. Pandit, M. K., Godhi, S., Lall, A. B. (2011). Preoperative Intravenous Tramadol Versus Diclofenac for Preventing Postoperative Pain After Third Molar Surgery: A Comparative Study. Journal of Maxillofacial and Oral Surgery, 10 (4), 306–309. doi: http://doi.org/10.1007/s12663-011-0250-9
  22. Alijanpour, E., Khirkhah, F., Bijani, A., Rabiee, M., Jabbari, A., Mortazavi, Y. (2011). Comparison of sodium diclofenac, ketamine and propofol with fentanyl and midazolam in balanced anaesthesia. Anesthesia: Essays and Researches, 5 (2), 176–181. doi: http://doi.org/10.4103/0259-1162.94760
  23. Seymour, R. A., Moore, U., Hawkesford, J., Coulthard, P., Jackson-Leech, D., Thomas, D. et. al. (2000). An investigation into the efficacy of intravenous diclofenac in post-operative dental pain. European Journal of Clinical Pharmacology, 56 (6-7), 447–452. doi: http://doi.org/10.1007/s002280000177
  24. Zohar, E., Shapiro, A., Eidinov, A., Fishman, A., Fredman, B. (2006). Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. Journal of Clinical Anesthesia, 18 (6), 415–421. doi: http://doi.org/10.1016/j.jclinane.2006.01.001
  25. McNicol, E. D., Ferguson, M. C., Schumann, R. (2018). Single-dose intravenous diclofenac for acute postoperative pain in adults. Cochrane Database of Systematic Reviews. doi: http://doi.org/10.1002/14651858.cd012498.pub2
  26. Colucci, R. D., Wright, C., Mermelstein, F. H., Gawarecki, D. G., Carr, D. B. (2009). 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, 11 (1), 15–21. doi: http://doi.org/10.1016/j.acpain.2008.11.001
  27. Mermelstein, F., Hamilton, D. A., Wright, C., Lacouture, P. G., Ramaiya, A., Carr, D. B. (2013). Single-Dose and Multiple-Dose Pharmacokinetics and Dose Proportionality of Intravenous and Intramuscular HPβCD-Diclofenac (Dyloject) Compared with Other Diclofenac Formulations. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 33 (10), 1012–1021. doi: http://doi.org/10.1002/phar.1304
  28. Chelly, J. E., Lacouture, P. G., Reyes, C. R. D. (2018). Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs & Aging, 35 (3), 249–259. doi: http://doi.org/10.1007/s40266-018-0529-3
  29. Leuratti, C., Loprete, L., Rossini, M., Frangione, V., Rovati, S., Radicioni, M. (2019). Pharmacokinetics and Safety of a Diclofenac Sodium 75 mg/1 mL Solution (Akis®/Dicloin®) Administered as a Single Intravenous Bolus Injection in Healthy Men and Women. European Journal of Drug Metabolism and Pharmacokinetics, 44 (5), 681–689. doi: http://doi.org/10.1007/s13318-019-00558-8
  30. Gan, T. J., Singla, N., Daniels, S. E., Lacouture, P. G., Min, L. H., Reyes, C. R. D., Carr, D. B. (2016). Cardiovascular safety of hydroxypropyl-β-cyclodextrin–diclofenac in the management of acute postsurgical pain: a pooled analysis of 2 randomized, double-blind, placebo- and active comparator–controlled phase III clinical trials. Journal of Clinical Anesthesia, 31, 249–258. doi: http://doi.org/10.1016/j.jclinane.2016.01.020
  31. Forrest, J. B., Camu, F., Greer, I. A., Kehlet, H., Abdalla, M., Bonnet, F. et. al. (2002). Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. British Journal of Anaesthesia, 88 (2), 227–233. doi: http://doi.org/10.1093/bja/88.2.227

Downloads

Published

2020-02-28

How to Cite

Litvinova, E. (2020). Analysis of clinical efficacy and safety of intravenous use of diclofenac for the prevention of postoperative pain: current status and strategic aspect. ScienceRise: Pharmaceutical Science, (1 (23), 34–38. https://doi.org/10.15587/2519-4852.2020.197338

Issue

No. 1 (23) (2020)

Section

Pharmaceutical Science

License

Copyright (c) 2020 Elena Litvinova

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.