Efectividad de la profilaxis analgésica con clonixinato de lisina en exodoncias: ensayo clínico aleatorio.

Pedro Aravena; Bruna Benso; Alejandra Bertín; Rocío Aravena-Torres

doi:10.17126/joralres.2013.028

Pedro Aravena Instituto de Anatomía, Histología y Patología, Facultad de Medicina, Universidad Austral de Chile.
Bruna Benso Department of Physiological Sciences, Piracicaba School of Dentistry, State University of Campinas, Piracicaba, Brazil
Alejandra Bertín Practica Privada
Rocío Aravena-Torres Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile.

DOI: https://doi.org/10.17126/joralres.2013.028

Abstract

Resumen: Objetivo: Evaluar la efectividad de la profilaxis analgésica con dosis únicas de clonixinato de lisina (CL 125mg) en pacientes sometidos a extracciones dentales. Metodología: Ensayo clínico aleatorio, doble enmascaramiento placebo-controlado. Participaron pacientes ASA I y II con indicación de exodoncia dental de servicios públicos en la ciudad de Valdivia-Chile en el mes de octubre del 2012. Se asignó de manera aleatoria dos grupos: un grupo tratamiento quienes recibieron una dosis de 125mg de CL 15 minutos antes de la cirugía; y un grupo control quien recibió un placebo. A ambos grupos se indicó CL como analgésico de rescate. Mediante un cuestionario, los pacientes registraron el grado de dolor a través de una Escala Visual Análoga (EVA) durante primer día en las 7 primeras horas, después de 24 y a las 48 horas posterior a la cirugía. Además, se registró número de cápsulas de CL consumidos como rescate durante 3 días posteriores a la intervención. Se comparó el efecto analgésico observado (EVA) y el número de consumo de analgésicos adicionales entre ambos grupos mediante t-test (p<0,05). Resultados: Cincuenta y cuatro pacientes fueron intervenidos. No se encontró diferencia estadísticamente significativa entre las puntuaciones de dolor entre ambos grupos. Los pacientes con profilaxis de CL informaron similar consumo de números de cápsulas de rescate que el grupo control. Conclusión: La profilaxis analgésica con CL no demostró ser más efectiva en la reducción del dolor luego de extracciones dentales en comparación al uso de placebo y dosis postquirúrgicas.

Palabras clave: Analgesia, Antiinflamatorio no Esteroideo, Extracción dental, Premedicación.

Effectiveness of preemptive lysine clonixinate in tooth extraction: A randomized controlled trial.

Abstract: Aim: To evaluate the effectiveness of prophylaxis with single-dose analgesic clonixinate lysine (CL 125 mg) in patients undergoing tooth extraction. Methods: A double-blind randomized placebo-controlled trial. Were included in the study patients ASA I and II with dental extraction indication in the city of Valdivia, Chile in October 2012. Were randomly assigned in two groups: the treatment group received a doses of 125mg of CL fifteen minutes before the surgery, and a control group who received placebo. Both groups used a CL as a rescue analgesic. Using a survey, patients reported the degree of pain via a visual analog scale (VAS) during the first day, at 24 and 48 hours after surgery. In addition, registered the number of CL capsules consumed as a ransom for 3 days after the surgery. We compared the analgesic effect observed in (VAS) and the number of additional analgesic consumption between the two groups using t-test (p <0,05). Results: Fifty-four patients were operated and there was no statistically significant difference between the pain scores between the two groups. Premedication patients reported the use of equal number of rescue capsules comparing with the control group. Conclusion: CL analgesic prophylaxis proved no more effective in reducing pain after tooth extraction when comparing to the use of placebo in a postoperative doses.

Keywords: Lysine clonixinate, "Analgesia"[MeSH], "Premedication"[MeSH], "Anti-Inflammatory Agents, Non-Steroidal"[MeSH], "Tooth Extraction"[MeSH].

References

1. Woolf CJ. Evidence for a central component of postinjury pain hypersensitivity. Nature. 1983; 306: 686–688.
2. Ferreira SH. The role of interleukins and nitric oxide in the mediation of inflammatory pain and its control by peripheral analgesics. Drugs. 1993; 46(Suppl 1): 1-9.
3. Ferreira SH. Peripheral analgesic sites of action of anti-inflammatory drugs. Int J Clin Pract Suppl. 2002; 128: 2-10.
4. Kaczmarzyk T, Wichlinski J, Stypulkowska J, Zaleska M, Woron J. Preemptive effect of ketoprofen on postoperative pain following third molar surgery. A prospective, randomized, double-blinded clinical trial. Int J Oral Maxillofac Surg. 2010; 39(7): 647-52.
5. Aznar-Arasa L, Harutunian K, Figueiredo R, Valmaseda-Castellón E, Gay-Escoda C. Effect of preoperative ibuprofen on pain and swelling after lower third molar removal: a randomized controlled trial. Int J Oral Maxillofac Surg. 2012; 41(8): 1005-9.
6. Krymchantowski AV, Carneiro H, Barbosa J, Jevoux C. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study. Arq Neuropsiquiatr. 2008; 66(2A): 216-20.
7. Massey T, Derry S, Moore RA, McQuay HJ. Topical NSAIDs for acute pain in adults. Cochrane Database Syst Rev. 2010; 16(6): CD007402.
8. Pérez-Urizar J. Preemptive analgesic effectiveness of oral ketorolac plus local tramadol after impacted mandibular third molar surgery. Med Oral Patol Oral Cir Bucal. 2011;16(6):e776-80.
9. Quiralte J, Blanco C, Castillo R, Delgado J, Carrillo T. Intolerance to nonsteroidal antiinflammatory drugs: Results of controlled drug challenges in 98 patients. J Allergy Clin Immun. 1996;98:678-85.
10. de Souza Amorim, K., Ayres, L. C. G., & da Cunha, R. S. Efeito comparativo entre clonixinato de lisina e paracetamol no controle da dor pós-exodontia. Rev Dor. 2012; 13(4): 356-9
11. Noronha VR, Gurgel GD, Alves LC, Noman-Ferreira LC, Mendonça LL, Aguiar EG, Abdo EN. Analgesic efficacy of lysine clonixinate, paracetamol and dipyrone in lower third molar extraction: a randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2009; 14(8): e411-5.
12. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med.2010;4(1):e60-8.
13. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013. En prensa.
14. Malamed SF. Manual de Anestesia Local. 5ta edición. Madrid: Editorial Elsevier; 2006.
15. Raspall G. Cirugía Oral e implantología. 2da edición. Buenos Aires: Editorial Médica Panamericana; 2006.
16. Halabí D, Escobar J, Muñoz C, Uribe S. Logistic regression analysis of risk factors for the development of alveolar osteitis. J Oral Maxillofac Surg. 2012; 70(5): 1040-4.
17. Goodwin SA. A review of preemptive analgesia. J Perianesth Nurs. 1998; 13(2): 109-14.
18. Pozos AJ, Martínez R, Aguirre P, Pérez J. Tramadol administered in a combination of routes for reducing pain after removal of an impacted mandibular third molar. J Oral Maxillofac Surg. 2007; 65(8): 1633-9.
19. Aznar-Arasa L, Harutunian K, Figueiredo R, Valmaseda-Castellón E, Gay-Escoda C. Effect of preoperative ibuprofen on pain and swelling after lower third molar removal: a randomized controlled trial. Int J Oral Maxillofac Surg. 2012; 41(8): 1005-9.
20. Ong KS, Seymour RA, Chen FC. Preoperative ketorolac has a preemptive effect for postoperative third molar surgical pain. Int J Oral Maxillofac Surg. 2004; 33(8): 771-6.
21. Marcelín-Jiménez G, Angeles AC, García A, Morales M, Rivera L, Martín-Del-Campo A. Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions. Int J Clin Pharmacol Ther. 2010; 48(5): 349-54.
22. Suazo IC, Cantín MG, Zavando DA. Análisis de la densidad de receptores tipo NMDA R1 en el núcleo espinal de trigémino humano. Rev Soc Esp. 2008; 15(6): 371-76.
23. Bustamante D, Paeile C, Willer JC, Le Bars D. Effects of intrathecal or intracerebroventricular administration of nonsteroidal anti-inflammatory drugs on a C-fiber reflex in rats. J Pharmacol Exp Ther. 1997; 281(3): 1381-91.
24. Grape S, Tramer MR. Do we need preemptive analgesia for the treatment of postoperative pain? Best Pract Res Clin Anaesthesiol. 2007; 21(1): 51-63.
25. Kelly DJ, Ahmad M, Brull SJ. Preemptive analgesia II: recent advances and current trends. Can J Anaesth. 2001; 48(11): 1091-101.
26. Al-Khateeb TH, Alnahar A. Pain experience after simple tooth extraction. J Oral Maxillofac Surg. 2008;66(5):911-7.
27. Gordon SM, Mischenko AV, Dionne RA. Long-acting local anesthetics and perioperative pain management. Dent Clin North Am. 2010;54(4):611-20.