I.V. Levetiracetam versus Phenobarbitone in Neonatal Seizures A Randomized, Single Blind Prospective Clinical Trial
Published on: 2017-12-18
Objective: Seizures in neonates are relatively common. Only few studies are available about the safety and efficacy of antiepileptic drugs used for treatment of neonatal seizures. The standard treatment has been Phenobarbitone (PB). Usually it is given as intravenous (I.V.) and followed when it is successful, by the oral form. Recently Levetiracetam (LEV) was studied with promising results. Here we compare the safety and efficacy of LEV with PB in the treatment of neonatal seizures. Methods: This is a randomized single blind study conducted at King Fahd medical city: a tertiary care hospital in Saudi Arabia between 2008 and 2015. The Institution Review Board approved the study. Parental agreement was obtained by signing informed consent prior to participation in the study. It is monophasic 22 neonates (birth to 28 days of age) with clinical seizures were recruited from the Neonatal Intensive Unit. They were randomized into 2 groups, group1 or 2, utilizing one of the readily available programs of randomization on the Internet. Group 1: treated with I.V. PB with possible switch to I.V. LEV if the former fails, while group 2 treated with I.V. LEV with possible switch to PB if the former fails. Treatment was randomly chosen and given by the Neonatal Intensive Care nurse as prescribed by physician on duty (patients do not know which drug is used). Seizure classification was adopted from Volpe.. Clinical detection was the essence of diagnosing seizures. This reflected practical choice due to the non-availability of handy electroencephalograms (EEGs).