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Recruiting Phase 2, Phase 3 NCT07095842

Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)

Trial Parameters

Condition Convulsive Status EPILEPTICUS
Sponsor Sohag University
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 668
Sex ALL
Min Age 2 Years
Max Age 16 Years
Start Date 2025-08-03
Completion 2026-07-30
Interventions
KetamineMidazolam

Brief 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 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 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).

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