IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
Condition: Tonic-clonic Seizure
MeSH terms: Seizures; Emergencies
Intervention: Keppra; Fosphenytoin; Dilantin
Intervention description: The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes.; IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals.; IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals.
Intervention MeSH terms: Phenytoin; Fosphenytoin; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tonic-clonic seizure; emergency department; IV levetiracetam; Keppra; seizures; phenytoin; Dilantin; Grand Mal seizure

Summary:

      This study is looking at three seizure medicines. Patients with seizures are usually treated
      with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or
      by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also.
      This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra)
      in patients who have had a recent seizure. Only patients with a history of seizures can be
      involved. The patient must present to the emergency department within 4 hours of a seizure.
      The purpose of this study is to compare these three drugs, phenytoin (Dilantin),
      fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs
      can prevent another seizure in the next 24 hours. We are also looking for any possible side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 or older

          -  patient presenting to Grady Memorial Hospital's Emergency Department after having a
             tonic-clonic seizure (primary or secondarily generalized) within the last 4 hours

        Cause of seizure for inclusion: reason for seizure is often undetermined at time of
        presentation to the Emergency Department. The most likely expected causes of a seizure are
        noncompliance to existing antiepileptic drug regimen, refractory epilepsy with breakthrough
        seizure, metabolic aberration, alcohol withdrawal, or unknown.

        Exclusion Criteria:

          -  non-English speaking

          -  first time seizure

          -  seizures other than tonic-clonic seizure (primary or secondarily generalized)

          -  more than 3 seizures in 24 hours or status epilepticus, pregnant patients by history
             or by urine pregnancy testing, serious neurologic insult resulting in seizure but
             where seizure is not the primary reason for admission (e.g. traumatic brain injury
             with seizure or hemorrhagic stoke would be excluded)

          -  contraindication to IV levetiracetam

          -  received IV phenytoin within 24 hours

          -  known allergy to phenytoin

          -  previously enrolled in the study