Objectives: To assess the efficacy of intermittent rectal diazepam prophylaxis in the prevention
of recurrent febrile seizures (FS).
Material and Methods: In a prospective randomized controlled trial 139 children (77 females, 62 males),
who experienced a first FS, were allocated to intermittent rectal diazepam prophylaxis
(n=68) or to no prophylaxis (n=71) and followed for 3 years. The inclusion criteria
were: no personal history of afebrile seizures, normal neurodevelopment, no previous
anticonvulsant therapy and age between 6 months and 3 years. There were no significant
differences between the two groups in respect of sex, type, age at onset and duration
of convulsions. Both groups were stratified to low, intermediate and high risk according
to five major risk factors (RF) for recurrent FS: age at onset ≤ 15 months, family
history of epilepsy, FS in first degree relatives, a first complex FS and increased
febrile episodes. Diazepam (0.33mg/kg BW) was administered three times the first day
and twice the second day of a febrile illness. All children had an electroencephalographic
(EEG) recording within a few days after apyrexia.
Results: The number of recurrences during the follow up period was 38 in the diazepam group
and 103 in the control group. The 36-month recurrence rates to the no prophylaxis
group were 82.6% in the high-risk patients (three or more RF), 55% in the intermediate
(two RF) and 46.43% in the low-risk ones (one or none RF). In the prophylaxis group
the recurrence rates were reduced in all risk groups: 38.1%, 35% and 33.33% respectively.
High numbers of recurrences were found because the vast majority of all children (56%)
randomly were aged 15 months or less at their first FS. Recorded side effects were
minor and transient.
Conclusions: Diazepam given rectally at times of fever substantially reduces the recurrence rate
mainly in high-risk children provided that sufficient doses are given timeously and
compliance problems are limited.
