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

NCT07095842 | Recruiting Phase 2

• 1 other identifier: Soh-Med-25-7-4PD
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

Convulsive Status EPILEPTICUS

Outcome Measures

Primary Outcomes (1)

• Number of participants with cessation of seizures at the time of hospital arrival

  Number of participants with cessation of clinically evident seizures at the time of hospital arrival

  At the time of hospital arrival (up to 1 hour)

Secondary Outcomes (7)

• Number of participants with sustained cessation of seizures

  From 10 minutes after study drug administration to 60-minutes after hospital arrival

• Number of participants with recurrence of seizures

  From 10 minutes after study drug administration to 60-minutes after hospital arrival

• Number of participants underwent endotracheal intubation

  60 minutes after hospital arrival

• Number of participants with severe hypotension

  At the time of hospital arrival (up to 1 hour)

• Number of participants with severe hypertension

  At the time of hospital arrival (up to 1 hour)

Study Arms (2)

Ketamine + Midazolam

EXPERIMENTAL

Drug: Ketamine; Drug: Midazolam

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Interventions

Ketamine DRUG

Intramuscular ketamine 2 mg/kg (max 90 mg)

Ketamine + Midazolam

Midazolam DRUG

Intramuscular midazolam 0.2 mg/kg (max 10 mg)

Ketamine + Midazolam; Midazolam

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Department of Pediatrics at Sohag University Hospital

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Status Epilepticus

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Elsayed Abdelkreem

CONTACT

1114232126; d.elsayedmohammed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: This is a pragmatic, decentralized, pre-consented, event-driven randomized controlled trial. The investigators aim to recruit and pre-randomize up to 668 patients who meet the eligibility criteria. These participants will be randomized to receive either add-on intramuscular ketamine combined with a second dose of midazolam, or a second dose of midazolam alone, in the event of convulsive status epilepticus (CSE) that is not terminated by an initial dose of midazolam. The sample size has been calculated to ensure that approximately 100 participants will experience the qualifying event (CSE not responding to first-dose midazolam) and receive the assigned study medications, anticipating that 50 will receive ketamine plus second-dose midazolam and 50 will receive the second dose of midazolam alone.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: August 3, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)