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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sohag, Egypt
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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