RecruitingPhase 2Phase 3NCT07095842
Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus
Sponsor
Sohag University
Enrollment
668 participants
Start Date
Aug 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 2 YearsMax Age: 16 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
- Having subsequent events (only the index event will be included).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGKetamine
Intramuscular ketamine 2 mg/kg (max 90 mg)
DRUGMidazolam
Intramuscular midazolam 0.2 mg/kg (max 10 mg)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07095842