Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
Recruiting · NCT07095842 · Interventional (participants receive a specific treatment) · Lead sponsor: Sohag University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
2 Years to 16 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- Department of Pediatrics at Sohag University Hospital - Sohag, Egypt