STUDY OBJECTIVE: To determine the effectiveness of IV phenytoin in the prevention of recurrent alcohol-related seizures during a six-hour observation period. DESIGN: Prospective, randomized, double-blind trial comparing IV phenytoin with normal saline placebo, conducted from January 1990 through December 1991. SETTING:Emergency department of an inner-city, university-affiliated, teaching hospital. PARTICIPANTS: One hundred forty-seven consecutive adults more than 25 years of age who presented with a witnessed generalized seizure in the setting of chronic alcohol abuse. INTERVENTIONS: Eligible subjects received 15 mg/kg of phenytoin or normal saline at an equivalent volume over 20 minutes by IV pump. Patients were observed for six hours in the ED after drug administration. Those experiencing a second seizure were admitted to the hospital. RESULTS:One hundred patients completed the study. Recurrent alcohol-related seizures occurred in ten of 49 patients (20.4%) in the phenytoin group and in 12 of 51 patients (23.5%) in the placebo group. chi 2 analysis revealed no statistically significant difference between the two groups (chi 2 = 0.142; P = .706). The 95% confidence interval for the difference was -0.13 to + 0.19. The relative risk of recurrence between groups was 0.868 with a 95% confidence interval of 0.412 to 1.826. CONCLUSION: No significant benefit of phenytoin administration in the prevention of recurrent alcohol-related seizures during a six-hour observation period was demonstrated.
RCT Entities:
STUDY OBJECTIVE: To determine the effectiveness of IV phenytoin in the prevention of recurrent alcohol-related seizures during a six-hour observation period. DESIGN: Prospective, randomized, double-blind trial comparing IV phenytoin with normal saline placebo, conducted from January 1990 through December 1991. SETTING: Emergency department of an inner-city, university-affiliated, teaching hospital. PARTICIPANTS: One hundred forty-seven consecutive adults more than 25 years of age who presented with a witnessed generalized seizure in the setting of chronic alcohol abuse. INTERVENTIONS: Eligible subjects received 15 mg/kg of phenytoin or normal saline at an equivalent volume over 20 minutes by IV pump. Patients were observed for six hours in the ED after drug administration. Those experiencing a second seizure were admitted to the hospital. RESULTS: One hundred patients completed the study. Recurrent alcohol-related seizures occurred in ten of 49 patients (20.4%) in the phenytoin group and in 12 of 51 patients (23.5%) in the placebo group. chi 2 analysis revealed no statistically significant difference between the two groups (chi 2 = 0.142; P = .706). The 95% confidence interval for the difference was -0.13 to + 0.19. The relative risk of recurrence between groups was 0.868 with a 95% confidence interval of 0.412 to 1.826. CONCLUSION: No significant benefit of phenytoin administration in the prevention of recurrent alcohol-related seizures during a six-hour observation period was demonstrated.