Background: In a prospective controlled study we evaluated the efficacy of intermittent diazepam prophylaxis in the recurrence rate of febrile seizures (FS).
Patients: A total of 139 children aged between 6 and 36 months, who had a first FS, were enrolled in the study and were randomly allocated to two groups: group (A) that received diazepam prophylaxis and group (B) without prophylaxis.
Methods: All children were followed up for at least 3 years after their first FS. The prophylaxis group (n = 68) received rectal diazepam the first two days of a febrile illness, whenever the temperature was > 38 degrees C (0.33 mg/kg every 8 h on the first day, and 0.33 mg/kg every 12 h on the second day of fever, max. dosage 7.5 mg). The no-prophylaxis group (n = 71) did not receive any prophylaxis at all. Each group was stratified to low, intermediate and high risk subgroups according to the following clinical data: age at the first febrile seizure </= 15 months, positive family history of febrile seizure or epilepsy in first degree relatives, complex first febrile seizure and frequent febrile illness.
Results: The 3-year recurrence rates in the no-prophylaxis group were 83 % in high- risk, 55 % in intermediate-risk and 46 % in low-risk patients. In the prophylaxis group we established a reduction of febrile seizure recurrence at 38 %, 35 % and 33 % in the three risk subgroups respectively.
Conclusion: The intermittent prophylaxis with rectal diazepam during febrile episodes lead to a reduction of febrile seizure recurrence, especially in high-risk patients. The results of our study set the indication for the use of intermittent diazepam prophylaxis in this subgroup.