Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    144
  • sponsor
    Sohag University
Updated on 18 July 2021

Summary

Generalized status epilepticus is a common pediatric neurological emergency with significant mortality and morbidity. Benzodiazepines remain the first anticonvulsive line but benzo-diazepines don't control seizures in about 30% of cases. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines such as Levetiracetam, acting by different pathways. This study aims to evaluate the effectiveness of combined levetiracetam and midazolam in treatment of generalized convulsive status epilepticus in children.

Description

Generalized convulsive status epilepticus (GCSE) is a common pediatric neurological emergency with an annual incidence of up to 73 episodes per 100,000 children and is associated with mortality in 2.7% of cases and overall morbidity in 10% - 20% of cases, including hemodynamic instability and long-term neurological impairments.

The management of GCSE in children starts with emergency measures (stabilization phase) with monitoring and laboratory testing in the first 5 minutes. Benzodiazepines are used as first-line anticonvulsants for GCSE that persists for more than 5 minutes. However, studies have shown that benzo-diazepines don't control GCSE in about 30% of patients. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines, acting by different pathways.

Levetiracetam is a recent broad-spectrum antiepileptic drug with a relatively high safety profile. The effectiveness of intravenous levetiracetam has been demonstrated as a second-line anticonvulsant in GCSE. In this study, we aim to evaluate the effectiveness and safety of levetiracetam plus midazolam versus midazolam alone as first-line therapy of GCSE in children.

Details
Condition Status Epilepticus, convulsive status epilepticus
Treatment Placebo, Midazolam, Levetiracetam
Clinical Study IdentifierNCT04926844
SponsorSohag University
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Generalized convulsive status epilepticus, which is clinically defined at the time of presentation as continuous, generalized, tonic-clonic seizure activity or 2 generalized tonic-clonic seizures without recovery of consciousness for more than 5 minutes

Exclusion Criteria

Failure to obtain informed consent
Prior therapy with any anticonvulsant for the presenting episode of generalized convulsive status epilepticus
Epileptic patients on levetiracetam therapy
Known allergy or contraindications to any of the study drugs
End-stage kidney disease
Severe liver disease
Cardiac diseases
Hypoglycemia or hyperglycemia
Inborn errors of metabolism
Known mood/behavioral disorder
Failure to obtain intravenous access in the first 5 minutes
Cessation of seizures during the stabilization phase (0 - 5 minutes)
Traumatic brain injury
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