Background: Until present time, suggested treatments for superficial thrombophlebitis induced by intravenous infusion (TFSI), are of uncertain effectiveness and most of them or empirical and not fully researched. The aim of this 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 and 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 groups: G-control (n = 40), without treatment; G-topical (n = 40), diclofenac emulsion gel used in a topical way on the concerned area every 8 hours during 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 quantifying flushing, tumor, heatness and pain. These data were compared considering the averages of differences registered in T2 with respect to T0. A decrease of intensity of TFSI > or = 30% was considered a positive answer to this treatment. The quantitative variables were studied with ANOVA, Kruskal-Wallis test or general linear model and the qualitative with the chi 2 test with Yates correction. The level of significance used was alpha = 0.05.
Results: The averages of differences in the intensity of TFSI that were registered 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 answers 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) and local pruritus 5-2 (p = 0.2). The treatment did not report serious adverse reactions in either of the groups.
Conclusion: The topical treatment of diclofenac can be recommended as an alternative simple, effective and safe therapy for patients who develop TFSI.