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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Levetiracetam; Midazolam

Criteria

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