ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Aug. 1980, p. 349-352 0066-4804/80/08-0349/04$02.00/0 Vol. 18, No. 2 Phlebitis Induced by Parenteral Treatment with Flucloxacillin and Cloxacillin: a Double-Blind Study AKE SVEDHEM,* KJELL ALESTIG, AND MARIANNE JERTBORN Department of Infectious Diseases, University of Gdteborg, (stra Sjukhuset, S-416 85 Gdteborg, Sweden Two studies were performed on a total of 54 patients with staphylococcal infections. Study I compares the phlebitogenic properties of flucloxacillin after intravenous infusions when either saline or sterile water was used as a solvent. No difference was observed between the two solvents, and the frequency of phlebitis for the total material without respect to solvents was 5% after 1 day of treatment and 13% after 2 days. Study II was a double-blind comparison of phlebitis caused by intravenous infusions of either flucloxacillin or cloxacillin. The frequencies of phlebitis were found to be 18 and 13%, respectively, after 2 days of treatment. The difference was not statistically significant. After 2 days of treatment the frequency of phlebitis increased dramatically for both drugs. All infusions were given through a plastic cannula of 5-cm length and 1.2-mm diameter. Severe staphylococcal infections are most of- ten treated intravenously with a penicillin of the isoxazolyl group. Although the phlebitogenic po- tential of the drug is important, it is commonly neglected because of a lack of knowledge and reported investigations in this field. When the drug is administered into a central vein these vasoirritant properties are noticed only when they have become severe. Few studies have been made to investigate local side effects of penicillins. A study per- formed in 1972 of the injurious effects of differ- ent penicillins on the aorta of rats showed that dicloxacillin produced the strongest effect, fol- lowed by cloxacillin, oxacillin, ampicillin, and penicillin G in that order (2). The damaging effect on the endothelium of the porcine aorta also showed that the most marked changes were caused by dicloxacillin, followed by cloxacillin and flucloxacillin (5). In 1975 a study of intra- venous dicloxacillin in humans resulted in phle- bitis in eight of ten patients (D. F. Busch and J. S. Rosenblatt, Program Abstr. Intersci. Conf. Antimicrob. Agents Chemother. 15th, Washing- ton, D.C., abstr. no. 54, 1975). Two cases of forearm gangrene were described in 1971 after inadvertent intraarterial injections of dicloxacil- lin (1). The study presented here reports on an inves- tigation of the local tolerance of the parenteral formulation of flucloxacillin in two trials. In study I, sterile water was alternated with saline when preparing the solutions for infusion to determine whether the solvent played any sig- nificant part in producing injurious effects on tissues. In study II flucloxacillin was compared with cloxacillin by using the double-blind tech- nique. For both studies all solutions of penicillins were administered every 8 h in intravenous in- fusions for 20 min. The infusions were given into a forearm vein. A plastic cannula (Venflon, Viggo, Halsingborg, Sweden; length, 5 cm; di- ameter, 1.2 mm) was used. After each infusion the cannula was filled with heparin solution and left in the vein. The cannula was not utilized for any other drugs or solutions. Daily inspections of the infusion sites were performed by the same person during both stud- ies. The following definitions were used to reg- ister side effects: pain = patient's subjective experience; erythema = erythema at a maximum of 2.5 cm above the infusion site and without palpable induration; phlebitis = erythema, tenderness, and induration 2.5 cm above the infusion site. Study I. The trials were conducted on 23 patients suspected of having staphylococcal sep- ticemia. The group consisted of 15 males and 8 females with a mean age of 45 years (range, 11 to 72 years). All patients received 2 g of fluclox- acillin (Heracillin, Astra, Sodertiilje, Sweden) at each infusion. During the first 48 h and after randomization of solvents, saline was used in 13 patients and sterile water was used in 10 pa- tients. After 48 h, the solvents were switched and the infusions were given in the opposite arm. The treatment was then allowed to continue as long as needed for the infection or until side effects occurred. Consecutive infusions in the same vein were regarded as a series. The infusions of flucloxacillin could be given 349 Downloaded from https://journals.asm.org/journal/aac on 17 April 2023 by 117.3.252.4.
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