Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II

Summary

Phase IIIb, multicenter, prospective, randomized, double-blind study to evaluate the fixed combination of Desketoprofen / Vitamin B in the management of acute pain in patients with cervical sprain grade I-II of the Quebec scale.

Timeline

Start

2021-11-23

Primary completion

2023-04-24

Completion

2023-04-25

Publications

• Background Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.
• Background Rodriquez AA, Barr KP, Burns SP. Whiplash: pathophysiology, diagnosis, treatment, and prognosis. Muscle Nerve. 2004 Jun;29(6):768-81. doi: 10.1002/mus.20060.
• Background Hartling L, Brison RJ, Ardern C, Pickett W. Prognostic value of the Quebec Classification of Whiplash-Associated Disorders. Spine (Phila Pa 1976). 2001 Jan 1;26(1):36-41. doi: 10.1097/00007632-200101010-00008.
• Background Bagan JV, Lopez Arranz JS, Valencia E, Santamaria J, Eguidazu I, Horas M, Forns M, Zapata A, Artigas R, Mauleon D. Clinical Comparison of Dexketoprofen Trometamol and Dipyrone in Postoperative Dental Pain. J Clin Pharmacol. 1998 Dec;38(S1):55S-64S. doi: 10.1002/jcph.1998.38.s1.55.
• Background Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.
• Background Curatolo M, Sveticic G. Drug combinations in pain treatment: a review of the published evidence and a method for finding the optimal combination. Best Pract Res Clin Anaesthesiol. 2002 Dec;16(4):507-19. doi: 10.1053/bean.2002.0254.
• Background Levin OS, Moseikin IA. [Vitamin B complex (milgamma) in the treatment of vertebrogenic lumbosacral radiculopathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(10):30-5. Russian.
• Background Kuhlwein A, Meyer HJ, Koehler CO. [Reduced diclofenac administration by B vitamins: results of a randomized double-blind study with reduced daily doses of diclofenac (75 mg diclofenac versus 75 mg diclofenac plus B vitamins) in acute lumbar vertebral syndromes]. Klin Wochenschr. 1990 Jan 19;68(2):107-15. doi: 10.1007/BF01646857. German.
• Background Perez-Flores E, Medina-Santillan R, Reyes-Garcia G, Mateos-Garcia E. Combination of diclofenac plus B vitamins in acute pain after tonsillectomy: a pilot study. Proc West Pharmacol Soc. 2003;46:88-90. No abstract available.
• Background Mibielli MA, Geller M, Cohen JC, Goldberg SG, Cohen MT, Nunes CP, Oliveira LB, da Fonseca AS. Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study. Curr Med Res Opin. 2009 Nov;25(11):2589-99. doi: 10.3111/13696990903246911.
• Background Gonzalez T, Balsa A, Sainz de Murieta J, Zamorano E, Gonzalez I, Martin-Mola E. Spanish version of the Northwick Park Neck Pain Questionnaire: reliability and validity. Clin Exp Rheumatol. 2001 Jan-Feb;19(1):41-6.
• Background Gaskell H, Derry S, Wiffen PJ, Moore RA. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2017 May 25;5(5):CD007355. doi: 10.1002/14651858.CD007355.pub3.
• Delgado-Garcia P, Alcocer-Herrera JB, Urenda-Quezada A, Alonso-Martinez MD, Bautista-Mendoza MA, Romero-Antonio Y, Mora-Villalobos JC, Sander-Padilla JG, Rios-Brito KF, Rodriguez-Vazquez IC, Gonzalez-Canudas J. A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine, Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic Grade I-II Cervical Sprains. Clin Drug Investig. 2024 Jun;44(6):413-424. doi: 10.1007/s40261-024-01370-2. Epub 2024 Jun 6.

Drugs

Indications

No indication recorded.