EFFICACY, SAFETY, AND COST-EFFECTIVE ANALYSIS OF LOW-DOSE ETORICOXIB AND ADD-ON PARACETAMOL VERSUS THERAPEUTIC DOSE ETORICOXIB FOR PAIN IN PATIENTS AFTER TOOTH EXTRACTION: A RANDOMIZED INTERVENTIONAL DOUBLE-BLIND STUDY
DOI:
https://doi.org/10.22159/ajpcr.2022.v15i5.44414Keywords:
Cost effective, Etoricoxib, Low dose, Pain, ParacetamolAbstract
Objectives: The objectives of the study were to study the efficacy, safety, and cost-effective analysis of low-dose etoricoxib and add-on paracetamol versus therapeutic dose etoricoxib in patients who experienced pain after tooth extraction.
Methods: Patients were recruited and randomized to two study groups E1P and E2 on etoricoxib 30 mg and add-on paracetamol 500 mg 8 hourly and etoricoxib 60 mg once respectively for 3 days. The efficacy was assessed by visual analog scale, pain relief score, and global evaluation score. Patients were assessed at 0, 6, 24, 48, and 72 h. Safety was assessed by adverse drug reactions reported by the patients after 72 h. Cost-effective analysis was done by calculating the cost of treatment and the cost-effective ratio in both groups.
Results: Eighty patients completed the study having 40 patients in each group. Mean pain intensity reduction, mean pain relief score, and global evaluation score all showed significantly better results (p<0.05) in Group E1P as compared to Group E2 at 6, 24, 48, and 72 h, respectively. No patient had reported any serious adverse drug reaction in both the groups; however, incidence of headache and fatigue was twice in the etoricoxib only treated group (n=4) than low-dose etoricoxib-treated group (n=2). The treatment cost of Group E1P was lesser than Group E2 and was also cost effective.
Conclusion: Low-dose etoricoxib with add-on paracetamol is a better analgesic than therapeutic dose etoricoxib and is also found to be safer and cost effective.
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References
DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. Pharmacotherapy A Pathophysiologic Approach, 10th ed. New York: McGraw-Hill Education; 2017. p. 255-8.
Al-Khateeb TH, Alnahar A. Pain experience after simple tooth extraction. J Oral Maxillofac Surg 2008;66:911-7. doi: 10.1016/j. joms.2007.12.008, PMID 18423280
Hersh EV, Moore PA, Grosser T, Polomano RC, Farrar JT, Saraghi M, et al. Nonsteroidal anti-inflammatory drugs and opioids in postsurgical dental pain. J Dent Res 2020;99:777-86. doi: 10.1177/0022034520914254, PMID 32286125
Bindu S, Mazumder S, Bandyopadhyay U. Non-steroidal anti-inflammatory drugs (NSAIDs) and organ damage: A current perspective. Biochem Pharmacol 2020;180:114147. doi: 10.1016/j. bcp.2020.114147
Bach-Rojecky L, Vađunec D, Žunić K, Kurija J, Šipicki S, Gregg R, et al. Continuing war on pain: A personalized approach to the therapy with nonsteroidal anti-inflammatory drugs and opioids. J Pers Med 2019;16:171-84. doi: 10.2217/pme-2018-0116
Kwiatkowska B, Majdan M, Mastalerz-Migas A, Niewada M, Skrzydło-Radomańska B, Mamcarz A. Status of etoricoxib in the treatment of rheumatic diseases. Expert panel opinion. Reumatologia 2017;55:290-7. doi: 10.5114/reum.2017.72626, PMID 29491537
Maniar KH, Jones IA, Gopalakrishna R, Vangsness CT. Lowering side effects of NSAID usage in osteoarthritis: Recent attempts at minimizing dosage. Expert Opin Pharmacother 2018;19:93-102. doi: 10.1080/14656566.2017.1414802, PMID 29212381
Tripathi KD. Pharmacotherapy, clinical pharmacology, and drug development. In: Essentials of Medical Pharmacology. 8th Revised Edition. New Delhi: Jaypee Brothers Medical Publishers; 2021. p. 222.
Thangaraju P, Varthya SB, Venkatesan S. Fixed-dose combinations: An essential for rational preparation. Ind J Pharmacol 2021;53:170-2. doi: 10.4103/ijp.IJP_133_19, PMID 34100402
Isola G, Matarese M, Ramaglia L, Iorio-Siciliano V, Cordasco G, Matarese G. Efficacy of a drug composed of herbal extracts on postoperative discomfort after surgical removal of impacted mandibular third molar: A randomized, triple-blind, controlled clinical trial. Clin Oral Investig 2019;23:2443-53. doi: 10.1007/s00784-018-2690-9,PMID 30311061
Daniels SE, Atkinson HC, Stanescu I, Frampton C. Analgesic efficacy of an acetaminophen/ibuprofen fixed-dose combination in moderate to severe postoperative dental pain: A randomized, double-blind, parallel-group, placebo-controlled trial. Clin Ther 2018;40:1765-76.e5. doi: 10.1016/j.clinthera.2018.08.019, PMID 30245281
Vaghela JH, Shah JH, Patel JH, Purohit BM. Comparison of safety and analgesic efficacy of diclofenac sodium with etodolac after surgical extraction of third molars: A randomized, double-blind, double-dummy, parallel-group study. J Dent Anesthesiol Pain Med 2020;20:19-27.
Gay-Escoda C, Hanna M, Montero A, Dietrich T, Milleri S, Giergiel E, et al. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/ paracetamol in moderate to severe acute pain: Results of a randomised, double-blind, placebo and active-controlled, parallel-group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open 2019;9:e023715. doi: 10.1136/bmjopen-2018-023715, PMID 30782886
Daniels SE, Bandy DP, Christensen SE, Boice J, Losada MC, Liu H, et al. Evaluation of the dose range of etoricoxib in an acute pain setting using the postoperative dental pain model. Clin J Pain 2011;27:1-8. doi: 10.1097/ajp.0b013e3181ed0639, PMID 21188849
Haglund B, Von Bültzingslöwen I. Combining paracetamol with a selective cyclooxygenase‐2 inhibitor for acute pain relief after third molar surgery: A randomized, double‐blind, placebo‐controlled study. Eur J Oral Sci 2006;114:293-301. doi: 10.1111/j.1600- 0722.2006.00365.x, PMID 16911100
Przybyła GW, Szychowski KA, Gmiński J. Paracetamol – An old drug with new mechanisms of action. Clin Exp Pharmacol Physiol 2020;48:3-19. doi: 10.1111/1440-1681.13392, PMID 32767405
Van Rensburg R, Reuter H. An overview of analgesics: NSAIDs, paracetamol, and topical analgesics Part 1. S Afr Fam Pract 2019;61 Suupp 1:S4-10. doi: 10.1080/20786190.2019.1610228
Ayoub SS. Paracetamol (acetaminophen): A familiar drug with an unexplained mechanism of action. Temperature (Austin) 2021;8:351-71. doi: 10.1080/23328940.2021.1886392, PMID 34901318
Kothari S, Singhal T, Bansal H. Evaluation of addition of paracetamol as add-on therapy to low dose etoricoxib for analgesia in acute pain: an experimental study. Int J Pharm Sci Res 2021;12:3508-12.
La Torre LF, Franco-González DL, Brennan-Bourdon LM, Molina- Frechero N, Alonso-Castro ÁJ, Isiordia-Espinoza MA. Analgesic efficacy of etoricoxib following third molar surgery: A meta-analysis. Behav Neurol 2021;2021:9536054. doi: 10.1155/2021/9536054, PMID 34539935
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