Continuous sodium valproate or phenobarbitone in the prevention of 'simple' febrile convulsions. Comparison by a double-blind trial.

Abstract

Of the 265 children aged 6-18 mo., admitted to hospital in a 26-mo. period, each with his 1st febrile convulsion, there were 64 who satisfied the criteria for a simple febrile convulsion. Of these, 43 (random) were entered into a double-blind trial of continuous sodium valproate vs. phenobarbitone, and 21 were untreated. The dosage was phenobarbitone 3-6 mg/kg per day; sodium valproate 30-60 mg/kg per day. Of the 39 patients who completed treatment (21 phenobarbitone, 18 sodium valproate) 2 in each group were withdrawn because of unacceptable side effects. Close supervision and random serum drug estimations showed compliance to be good. After a mean treatment period of 12 mo. (mean age 25 mo.) there was 1 recurrence in the sodium valproate group compared with 7 in the untreated group (P < 0.05) and 4 recurrences in the phenobarbitone group. The difference between treatment and no treatment was significant (P < 0.05). These results suggest that in simple febrile convulsions occurring from 6-18 mo. of age, sodium valproate is as effective as phenobarbitone in preventing recurrence and that either treatment is better than none.