Comparative efficacy and safety of intravenous valproate and phenytoin in children.

Author(s): Rai A, Aggarwal A, Mittal H, Sharma S

Affiliation(s): Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.

Publication date & source: 2011-11, Pediatr Neurol., 45(5):300-4.

Intravenous loading is required to reach therapeutic levels of antiepileptic drugs. Valproate, the drug of choice for most epilepsy, may be a better option than phenytoin. In total, 100 children (aged 3-12 years) with motor focal seizures or generalized seizures (second episode) were randomized to receive valproate (20 mg/kg) or phenytoin (20 mg/kg). Patients convulsing at presentation received diazepam. Pulse rate, respiratory rate, blood pressure, oxygen saturation, consciousness, and recurrence of seizures were monitored. The primary outcome measure was control of seizures for 24 hours. Secondary outcome measures comprised variations in cardiorespiratory parameters. The primary endpoint efficacy was 93% and 97%, respectively, in the two groups (P = 0.345). Sixteen children in the valproate group and 17 in the phenytoin group received diazepam, with time to cessation of seizures at 25.44 +/- 10.34 and 24.76 +/- 12.60 seconds, respectively (P = 0.90). The percentages of children with drug levels in therapeutic range at 4 hours and 24 hours were comparable (P > 0.05). Among children unconscious at presentation, time to regain consciousness was 58.33 +/- 28.50 minutes in the valproate only group, and 135.00 +/- 62.10 minutes in the phenytoin only group (P = 0.010). Changes in cardiorespiratory parameters were not significantly different (P > 0.05). Hence intravenous valproate is safe and efficacious, with less time to regain consciousness. Valproate can be included in treatment protocols for acute seizures. Copyright (c) 2011 Elsevier Inc. All rights reserved.