Comparison of the effectiveness of phenytoin and Levetiracetam and valproic acid in prevention of seizure of post traumatic brain hemorrahage

Comparing the effectiveness of phenytoin, Levetiracetam , and valproic acid in preventing seizures in hemorrhage caused by brain trauma.

Clinical trial with 3 intervention groups, with parallel groups, Double-blind, randomized, phase 3 on 225 patients. Block method was used for randomization with randomization.com online software.

225 brain trauma patients referred to Valiasr Hospital in Arak city, who were randomly divided into 3 groups and received one of the 3 commonly used injectable anticonvulsant drugs available in Iran . Then they will be evaluated within the first 24 hours and then up to 6 days.This study is double-blind and the patients or their legal guardians and the intern are not aware of the type of drug received, but the project manager and the analyzer will be aware of the type of drug received

Inclusion criteria: head trauma that requires prophylactic anticonvulsant treatment. Exclusion criteria: pregnancy, History of epilepsy, history of allergy to studied drugs

In the first intervention group, patients are treated with phenytoin with a loading dose of 20 mg/kg and injection within one hour and a maintenance dose of 5 mg/kg every day. First, they receive injectable medicine for 24 to 48 hours and then oral medicine. The second group: treatment with the drug Levetiracetam with a loading dose of 20 mg/kg and injection within one hour and a maintenance dose of 10 to 20 mg/kg per day. Patients first receive injectable medicine for 24 to 48 hours and then oral medicine.The third group: First, 15 mg/kg sodium valproate is administered by injection, and a maintenance dose of 15 mg/kg is administered in 2 to 3 divided doses every day. The patient first receives injectable medicine for 24 to 48 hours and then oral medicine.

Number of seizures

Randomization in this study will be done using block randomization method. In this way, 225 blocks of 3 were created randomly using randomization.com online software by the plan's statistical consultant and sealed in 225 envelopes with aluminum cover and numbered in the order of creation. Then, during the implementation of the plan, the created sequences will be removed from the envelopes and the patients will be assigned to groups A, B and C based on the sequence of each block.

Patients will be assigned to each treatment based on block randomization method.The study procedure and the requirement to receive an anticonvulsant drug after severe traumatic brain injury, which is one of the 3 injectable drugs available in Iran which are also the subject of our study, will be explained to patients or their legal guardians, and informed consent will be obtained. However, the patients or their legal guardian will not be aware of the type of drug received (out of the 3 drugs). Additionally, the medical intern, who is responsible for collecting data, will not be aware of the drug received and will recognize them into groups A, B, or C ; the project manager and the data analyst will be aware of the type of drug received by the patients.