Combined Ketamine and Midazolam Versus Midazolam Alone for Initial Control of Generalized Convulsive Seizures in Critically Ill Patients: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202511562566881

Enrollment

108

Registered

2025-11-26

Start date

2025-11-10

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases

Interventions

midazolam plus placebo

ketamine plus midazolam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 6 to 60 years who develop generalized convulsive seizures from various causes, including head trauma, whether seizures occur in the Emergency Department or in the ICU setting. Both male and female patients will be included.

Exclusion criteria

Exclusion criteria: Known hypersensitivity to midazolam or ketamine. Patients whose 1st degree relatives refuse to provide informed consent

Design outcomes

Primary

Measure	Time frame
cessation of clinical seizures at five minute study timepoint.	—

Secondary

Measure	Time frame
reduction of the requirement for a second midazolam bolus cessation of clinical seizures at 15, 35, and 55 minute timepoints 24-hour seizure control Adverse events (hypotension, desaturation, agitation, vomiting)	—

Countries

Egypt

Contacts

Public Contactahmed mohamed

lecturer

ahmedmohamed@med.sohag.edu.eg01006774710

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026