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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Intravenous levetiracetam 60 mg/kg (max 4500 mg) over 5 minutes (diluted with isotonic saline to a concentration of 50 mg/ml).
Intravenous midazolam 0.2 mg/kg (maximum 10 mg) over 2 minutes
Intravenous isotonic saline (1.2 ml/kg) over 5 minutes
Department of Pediatrics - Sohag University Hospital
Sohag, Egypt
Cessation of seizures
Cessation of clinical seizures at 20 minutes timepoint (end of first therapy phase)
Time frame: 20 minutes
Need for repeating midazolam
Need for repeating midazolam during the first therapy phase (5 - 20 min)
Time frame: 20 minutes
Cessation of seizures
Cessation of clinical seizures at 40 minutes timepoint (end of second therapy phase).
Time frame: 40 minutes
Seizure control
24-hours seizure control (no visually observed recurrence of seizures after the end of second phase therapy with improved sensorium)
Time frame: 24 hours
Hypotension
Occurrence of hypotension
Time frame: 24 hours
Need for mechanical ventilation
Need for mechanical ventilation
Time frame: 24 hours
Skin rash
Occurrence of skin rash
Time frame: 24 hours
Agitation/aggression
Occurrence of agitation/aggression
Time frame: 24 hours
Mortality
Occurrence of death
Time frame: 24 hours
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