Combined Ketamine and Midazolam for Generalized Convulsive Status Epilepticus (Ket-Mid)
Generalized Convulsive Status Epilepticus
About this trial
This is an interventional treatment trial for Generalized Convulsive Status Epilepticus focused on measuring Status epilepticus, Ketamine, Drug combination, Children, Pediatric
Eligibility Criteria
Inclusion Criteria: Age from 6 month to 16 years. Generalized convulsive status epilepticus, defined as > 5 minutes of clinically observed continuous or recurrent generalized, tonic-clonic seizure activity without regaining of consciousness. Exclusion Criteria: Failure to obtain informed consent. Previous treatment with any antiseizure medication for the presenting seizure episode. Hypertension Alcohol intake Conditions associated with increased intracranial pressure (e.g., central nervous system mass lesions, hydrocephalus) Glaucoma Known allergy or contraindications to any of the study drugs. End-stage kidney disease. End stage liver disease Arrhythmia, severe heart disease, or pulmonary hypertension. Hyperthyroidism Pheochromocytoma Hypoglycemia or hyperglycemia. Inborn errors of metabolism. Known or suspected psychiatric disorder. Failure to obtain intravenous access in the first 5 minutes of stabilization phase. Cessation of seizures during the stabilization phase (0 - 5 minutes). Traumatic brain injury.
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Study group (Ket-Mid)
Control group (Pla-Mid)
Children receiving ketamine + midazolam
Children receiving placebo + midazolam