The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.
Age from 2 to 16 years.
Established diagnosis of epilepsy of at least 1 year duration.
History of at least 1 episode of convulsive status epilepticus in the preceding 12 months.
Failure to obtain informed consent.
Known allergies or contraindications to ketamine.
Known contraindications to intramuscular injection.
Presence of another family member included in the same trial.
Parallel
Ketamine
DrugIntramuscular ketamine 2 mg/kg (max 90 mg)
Midazolam
DrugIntramuscular midazolam 0.2 mg/kg (max 10 mg)
Number of participants with cessation of seizures at the time of hospital arrival
Number of participants with cessation of clinically evident seizures at the time of hospital arrival
Number of participants with sustained cessation of seizures
Number of participants with sustained cessation of clinically evident seizures at 10 minutes after study drug administration to 60-min after hospital arrival with improved responsiveness (verbal communication, obeying commands, or purposeful reaction to painful stimuli) and no endotracheal intubation or use of any additional antiseizure medications or anticonvulsant sedatives
Number of participants with recurrence of seizures
Number of participants with recurrence of clinically evident seizures after initial control at 10 minutes after study drug adminstration till 60-minutes after hospital arrival
Number of participants underwent endotracheal intubation
Number of participants underwent endotracheal intubation at 60 minutes after hospital arrival
Number of participants with severe hypotension
Number of participants with severe hypotension at the time of hospital arrival
Click on the lead sponsor to view all of their trials.
