Combined Ketamine and Midazolam for Generalized Convulsive Status Epilepticus (NCT05779657) | Clinical Trial Compass
CompletedPhase 2/3
Combined Ketamine and Midazolam for Generalized Convulsive Status Epilepticus
Egypt144 participantsStarted 2023-03-21
Plain-language summary
Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children. Benzodiazepines are the recommended first line antiseizure medication (ASMs), but they fail to control seizures in a third of cases. Combination of benzodiazepines with another ASM that has a different mechanism of action may be a promising option for faster control of GCSE. In this study, the investigators aim to evaluate the efficacy and safety of ketamine plus midazolam versus midazolam alone as first-line therapy of pediatric GCSE.
Who can participate
Age range
6 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.