OBJECTIVE: To compare the effectiveness of intermittent clobazam versus diazepam therapy in preventing the recurrence of febrile seizures and assess adverse effects of each drug. METHODS: This prospective randomized controlled trial was performed on neurologically normal children aged from 6 months to 5 years with a history of simple febrile seizures and normal electroencephalogram without any evidence of acute central nervous system infection. The patients were randomly prescribed with oral clobazam (37 cases) or diazepam (35 cases) when they developed a febrile disease. They were advised to use the medications during the first 48 h of the onset of fever. All the patients were monitored regarding developing seizure and adverse effects of the drugs. All patients were followed for 12 months. RESULTS: Overall, 243 episodes of fever occurred during the period, including 116 episodes in the clobazam group and 127 episodes in the diazepam group. Recurrence of seizures occurred in 2 (1.7%) subjects in the clobazam group, and in 4(3.1%) cases in the diazepam group. (P value=0.474). Twenty cases (54%) in the diazepam group and 5 (14.2%) cases in the clobazam group developed drowsiness and sedation during the follow-up period (P value=0.0001). CONCLUSIONS: Intermittent clobazam therapy seems advantageous to diazepam due to similar efficacy but significantly lower adverse effects such as drowsiness and sedation.
RCT Entities:
OBJECTIVE: To compare the effectiveness of intermittent clobazam versus diazepam therapy in preventing the recurrence of febrile seizures and assess adverse effects of each drug. METHODS: This prospective randomized controlled trial was performed on neurologically normal children aged from 6 months to 5 years with a history of simple febrile seizures and normal electroencephalogram without any evidence of acute central nervous system infection. The patients were randomly prescribed with oral clobazam (37 cases) or diazepam (35 cases) when they developed a febrile disease. They were advised to use the medications during the first 48 h of the onset of fever. All the patients were monitored regarding developing seizure and adverse effects of the drugs. All patients were followed for 12 months. RESULTS: Overall, 243 episodes of fever occurred during the period, including 116 episodes in the clobazam group and 127 episodes in the diazepam group. Recurrence of seizures occurred in 2 (1.7%) subjects in the clobazam group, and in 4(3.1%) cases in the diazepam group. (P value=0.474). Twenty cases (54%) in the diazepam group and 5 (14.2%) cases in the clobazam group developed drowsiness and sedation during the follow-up period (P value=0.0001). CONCLUSIONS: Intermittent clobazam therapy seems advantageous to diazepam due to similar efficacy but significantly lower adverse effects such as drowsiness and sedation.
Authors: M L Manreza; J L Gherpelli; L R Machado-Haertel; C C Pedreira; C O Heise; A Diament Journal: Arq Neuropsiquiatr Date: 1997-12 Impact factor: 1.420