Effect of topical and oral diclofenac in superficial thrombophlebitis induced by intravenous infusion

BACKGROUND: Until present time, suggested treatments for superficial thromb ophlebitis induced by intravenous infusion (TFSI), are of uncertain effecti veness and most of them or empirical and not fully researched. The aim of t his report is to study the effectiveness and safety of the topical and oral administration of diclofenac in the treatment of TFSI. PATIENTS AND METHODS: In this prospective study 120 patients both female an d male were included. All of them developed TFSI during hospitalization and at the same time they were assigned at random to one of the following grou ps: G-control (n = 40), without treatment; G-topical (n = 40), diclofenac e mulsion gel used in a topical way on the concerned area every 8 hours durin g 48 hours; G-oral (n = 40), diclofenac 75 mg p.o. every 12 hours during 48 hours. The measurements were done at the moment of diagnosis of TFSI (T0) and 48 hours later (T2). Registries of intensity of TFSI were done by quant ifying flushing, tumor, heatness and pain. These data were compared conside ring the averages of differences registered in T2 with respect to T0. A dec rease of intensity of TFSI greater than or equal to 30% was considered a po sitive answer to this treatment. The quantitative variables were studied wi th ANOVA, Kruskal-Wallis test or general linear model and the qualitative w ith the chi(2) test with Yates correction. The level of significance used w as or = 0.05. RESULTS: The averages of differences in the intensity of TFSI that were reg istered in the groups G-control, G-topical and G-oral in T2 compared to T0 are: -0.12 (4.89), -5.70 (3.13), -4.82 (3.14) (p = 0.000). The favorable an swers in G-control, G-topical and G-oral were: 20, 60 and 60%, respectively (p = 0.0001). The adverse reactions in G-topical and G-oral were: headache 9-5 (p = 0.2), epigastric pain 4-17 (p = 0.0009), nausea 6-16 (p = 0.01) a nd local pruritus 5-2 (p = 0.2). The treatment did not report serious adver se reactions in either of the groups. CONCLUSION: The topical treatment of diclofenac can be recommended as an al ternative simple, effective and safe therapy for patients who develop TFSI.