OBJECTIVE: To evaluate the efficacy of intermittent clobazam therapy in preventing the recurrence of febrile seizures and to assess its safety. METHODS: The study was a prospective, randomized, double-blind placebo-controlled trial conducted in the Department of Child Health, Christian Medical College Hospital, Vellore between July 2001 and September 2002. Neurologically normal children between 6 months and 3 years of age with a history of febrile seizures and no evidence of acute CNS infection or EEG abnormality were included into the study. 19 children in a clobazam group and 20 in theplacebo group were randomly allocated. Temperature reduction measures with paracetamol and tepid sponging were advised to all children. In addition the dispensed medication was to be administered at the onset of fever and continued for 48 hours irrespective of the duration of fever. The children were then monitored for seizures and adverse effects of clobazam. The children were followed up for a mean period of 9.9 months. The analysis was done on the number of febrile episodes in both the groups. RESULTS: There were a total of 110 episodes of fever during the study period. Mean number of febrile episodes in the clobazam group was 3.1 and in placebo group 2.56. Six (12.5%) of the 48 episodes in placebo group and one (1.7%) of 60 episodes in clobazam group had seizure recurrence. This was statistically significant (p = 0.01). Drowsiness and weakness were present equally in both clobazam and placebo groups whereas ataxia was present only in the clobazam group, the difference being statistically significant (p=0.04). CONCLUSION: Intermittent clobazam therapy is an effective measure in the prevention of recurrence of febrile seizures. The ataxia due to clobazam was much lower than that reported with diazepam.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of intermittent clobazam therapy in preventing the recurrence of febrile seizures and to assess its safety. METHODS: The study was a prospective, randomized, double-blind placebo-controlled trial conducted in the Department of Child Health, Christian Medical College Hospital, Vellore between July 2001 and September 2002. Neurologically normal children between 6 months and 3 years of age with a history of febrile seizures and no evidence of acute CNS infection or EEG abnormality were included into the study. 19 children in a clobazam group and 20 in the placebo group were randomly allocated. Temperature reduction measures with paracetamol and tepid sponging were advised to all children. In addition the dispensed medication was to be administered at the onset of fever and continued for 48 hours irrespective of the duration of fever. The children were then monitored for seizures and adverse effects of clobazam. The children were followed up for a mean period of 9.9 months. The analysis was done on the number of febrile episodes in both the groups. RESULTS: There were a total of 110 episodes of fever during the study period. Mean number of febrile episodes in the clobazam group was 3.1 and in placebo group 2.56. Six (12.5%) of the 48 episodes in placebo group and one (1.7%) of 60 episodes in clobazam group had seizure recurrence. This was statistically significant (p = 0.01). Drowsiness and weakness were present equally in both clobazam and placebo groups whereas ataxia was present only in the clobazam group, the difference being statistically significant (p=0.04). CONCLUSION: Intermittent clobazam therapy is an effective measure in the prevention of recurrence of febrile seizures. The ataxia due to clobazam was much lower than that reported with diazepam.
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
Authors: N P Rosman; T Colton; J Labazzo; P L Gilbert; N B Gardella; E M Kaye; C Van Bennekom; M R Winter Journal: N Engl J Med Date: 1993-07-08 Impact factor: 91.245