Double-blind multicenter study on the efficacy and tolerability of cetirizine compared with oxatomide in chronic idiopathic urticaria in preschool children

Background: There are no studies on the use of cetirizine in children under the age of 6. Objective: We compared the efficacy and tolerability of cetirizine in patie nts with idiopathic chronic urticaria to the more widely used antihistamine , oxatomide. Methods: This double-blind study was performed on 62 patients (38 male and 24 female) with idiopathic chronic urticaria, recruited from four different medical centers of the national territory (Ancona, Cagliari, Catania, and Messina). The children's ages ranged from 2 to 6 years (mean 3.85). The pat ients were randomly assigned to two treatment groups: one group treated 31 children with cetirizine at a dosage of 5 mg q.d., and a second group treat ed 31 children for the same amount of time with oxatomide, at a dosage of 2 5 mg q.d. Sixty-two children began the treatment, but five did not finish t he study (three in the cetirizine and two in the oxatomide group). Thus, th e clinical study and the statistical evaluation were conducted on 57 childr en (28 cetirizine and 29 oxatomide). The Student's t test was used to compa re severity of the illness and changes in the hematochemical tests. Results: Overall, the effectiveness of the two medications in treating eryt hema, papules, edema, and itching showed comparable therapeutic activity (P < 0.001). Neither medication produced significant side effects. Conclusions: The results of the present study suggest that cetirizine may r epresent an effective and safe pharmacologic therapy for chronic urticaria in preschool children. There was no evidence for changes in hematochemical and urinary values, demonstrating the safety and the tolerability of the tw o antihistamines, even when given to young children.