Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 2 to 16

Early prehospital ketamine plus midazolam for convulsive status epilepticus in children with epilepsy

Official title: Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus

Run by Sohag University · NCT07095842 · Data updated 2026-11-12

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

PhasePhase2; Phase3
Study typeInterventional
Ages2 Years to 16 Years
SexAll
Enrollment668 (estimated)
SponsorSohag University
Academic / other
Locations1 site (Sohag)
StatusRecruiting
StartedAugust 3, 2025
Main results expectedJuly 30, 2026
Study endsAugust 1, 2026
Registry record updatedAugust 5, 2025
Trial IDNCT07095842 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Department of Pediatrics at Sohag University Hospital
    Sohag, Egypt
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.