Objectives: To compare efficacy and safety of buccal Clonazepam with I/V Midazolam in acute seizure therapy.
Methods:A prospective, open label randomized controlled trial done on children with acute breakthrough seizure in known epileptics .200 breakthrough episodes were randomized to inject able midazolam (0.2mg/kg) or buccal clonazepam (0.01mg/kg) given on even days (IV Midazolam) and odd days (buccal Clonazepam).Results: Ninety two (92.0%) seizures were controlled IV Midazolam and eighty six (86.0%) in buccal Clonazepam group. No statistical significant (p=0.175) was observed .Recurrence after initial control was 8.0% in IV Midazolam and 9.0% in buccal Clonazepam group with no statistical significant (p=0.800) .Vital monitoring parameters maintained in both groups .16.0% revealed adverse reactions 10 min post drug administration, 4.0% in the midazolam, and 12.0% in clonazepam group (p value=0.119). Adverse effects required no intervention.
Conclusions
MonitoringPatients were monitored for vital parameters including heart rate, respiratory rate, blood pressure, saturation for ten minutes. The side effects of each drug were compared in different age groups with different semiology and etiology of seizures. We used Clonazepam (0.25/0.50/1.00mg) mouth dissolving dispersible clonazepam tablets.
Statistical AnalysisData was recorded on a predesigned proforma and it was managed on a Microsoft Excel spread sheet. Statistical analysis was performed using software between the 2 groups: IV Midazolam and Buccal clonazepam. Categorical variables were summarized by frequency .Proportions were compared by chi-square test or Fisher's exact test (where expected frequency <5). Continuous variables having a normal distribution were summarized by mean and standard deviation; for others median was used .for continuous variables, student's 't' test , Mann Whitney U test or Wilcoxon signed rank sum test were applied as appropriate .P value of <0.05 was taken as significant .
ResultsThe baseline characteristics of two drug groups with respect to age, sex, etiology of seizures, types of seizure, duration of seizure,EEG,neuroimaging were statistically comparable (