Early prehospital ketamine plus midazolam for convulsive status epilepticus in children with epilepsy
Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus
PHASE2; PHASE3 · Sohag University · NCT07095842
This trial will test whether giving ketamine in addition to a second dose of midazolam before hospital arrival can stop convulsive status epilepticus in children with epilepsy ages 2–16.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 668 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07095842 on ClinicalTrials.gov |
What this trial studies
PEAK-SEEK is a pragmatic, decentralized, pre-consented, event-driven randomized controlled trial comparing add-on intramuscular ketamine to a second prehospital dose of midazolam versus standard midazolam-based care for pediatric convulsive status epilepticus. Eligible children are aged 2–16 years with an established epilepsy diagnosis of at least one year and a recent history of convulsive status epilepticus; enrollment occurs at the index prehospital event. Emergency responders administer the randomized intervention in the field to try to shorten seizure duration and reduce progression to refractory or prolonged status epilepticus. The trial is designed to reflect real-world emergency conditions and measure whether earlier combination therapy reduces seizure time and downstream complications compared with midazolam alone.
Who should consider this trial
Good fit: Children aged 2–16 with epilepsy for at least one year who have had at least one convulsive status epilepticus in the past 12 months and who experience convulsive status epilepticus before hospital arrival are the intended participants.
Not a fit: Children outside the age range, without an established epilepsy diagnosis, or with known allergies or contraindications to ketamine or intramuscular injection are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding early ketamine could stop seizures faster and reduce brain injury, long-term neurologic complications, and the need for intensive hospital care.
How similar studies have performed: Numerous observational studies report ketamine can terminate refractory status epilepticus, and the recent Ket-Mid randomized trial showed ketamine–midazolam was more effective than midazolam alone, though prehospital use is less tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Sohag
- Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: Elsayed Abdelkreem
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 1114232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Convulsive Status EPILEPTICUS