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Search / Trial NCT04926844

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

Launched by SOHAG UNIVERSITY · Jun 14, 2021

Trial Information

Current as of November 03, 2025

Completed

Keywords

Status Epilepticus Convulsions Children Seizures Benzodiazepines Midazolam Levetiracetam

ClinConnect Summary

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, stu...

Gender

ALL

Eligibility 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

About Sohag University

Sohag University is a distinguished academic institution located in Sohag, Egypt, committed to advancing healthcare through rigorous clinical research. As a clinical trial sponsor, the university leverages its robust infrastructure and multidisciplinary expertise to facilitate innovative studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. With a focus on ethical standards and scientific integrity, Sohag University collaborates with healthcare professionals and researchers to conduct trials that address critical health issues, ensuring the advancement of evidence-based practices in the healthcare community.

Locations

Sohag, Egypt

Patients applied

0 patients applied

Trial Officials

Abdelrahim A Sadek, MD, PhD

Study Chair

Sohag University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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