Abstract

RODRIGUEZ-LOPEZ, M. et al. Management of mild to moderate acute pain with ibuprofen lysinate: an observational study. Rev. Soc. Esp. Dolor [online]. 2004, vol.11, n.2, pp.21-29. ISSN 1134-8046.

Objectives: To study the effectiveness and the safety profile of ibuprofen lysinate in the treatment of mild to moderate acute pain in real clinical practice. Material and methods: Open label, multi-centre, observational and prospective follow-up study, carried out in normal clinical conditions. The participating number of investigators was of 263, which recruited 1,435 patients, among July 2001 and July 2002. The patients were of ambulatory origin, age 18 years, that consulted the doctor to be suffering mild to moderate acute pain (Visual Analog Scale of pain -VAS- 7). The observation period for each patient was of a maximum of 4 weeks, with a baseline visit at the beginning of the treatment, a follow-up visit to the week and a final visit in a maximum of 30 days. The assessment of the effectiveness was performed with the VAS, for all the patients in general, and also with the test of Lattinen for those patients with muscle-skeletal pain, and analyzing the mean time of disappearance of the pain as well as the duration of the therapeutic effect. The safety assessment was carried out by incidence of adverse reactions throughout the study. Results: The main reasons of inclusion that presented the patients were muscle-skeletal pain (60%), dentalgia (15%), headache (10%), dysmenorrhoea (10%) and post-surgical pain (3%). The decrease of the average scoring of the VAS among the baseline and intermediate visits was of 3.3 points, and among the intermediate and final visits was of 1.7 points; these differences were statistically significant (p <0.001). The first day of treatment, the 60% of patients reached the therapeutic effect in less than 20 minutes. The percentage increases to 74% the second day of treatment, and to the week, they were 84% the patients that reached the therapeutic effect in less than 20 minutes. The duration of the therapeutic effect after the first dose was enlarging progressively since the 5.6 hours the first day to the 7.6 hours to the seventh day. The decrease of the average scoring in the test of Lattinen among the baseline and intermediate visits was of 3.4 points, and among the intermediate and final visits was of 1.7 points; these differences were statistically significant (p <0.001). Only a 2.3% of the patients in the study had some adverse reaction, most of them of mild to moderate intensity. All the reactions were among the expected by the use of ibuprofen lysinate. Conclusions: Ibuprofen lysinate is a medication of a great therapeutic effectiveness (94% of the patients good-very good), of excel-lent tolerability (96% good-very good), with rapidity of therapeutic action (15-20 minutes of the administration) and a highly favourable relationship benefit-risk.

Keywords : Ibuprofen lysinate; Acute pain; Analgesia; NSAID.

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