Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
Recruiting
Phase 2
Phase 3
Interventional Study
Convulsive Status EPILEPTICUS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 16
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 668 (estimated)
- Sponsor
- Sohag University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Failure to obtain informed consent.
* Known allergies or contraindicati…
Contacts