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Combined Ketamine and Midazolam for Generalized Convulsive Status Epilepticus

NCT05779657 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-10-29

No results posted yet for this study

Summary

Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children. Benzodiazepines are the recommended first line antiseizure medication (ASMs), but they fail to control seizures in a third of cases. Combination of benzodiazepines with another ASM that has a different mechanism of action may be a promising option for faster control of GCSE. In this study, the investigators aim to evaluate the efficacy and safety of ketamine plus midazolam versus midazolam alone as first-line therapy of pediatric GCSE.

Conditions

  • Generalized Convulsive Status Epilepticus

Interventions

DRUG

Ketamine

Intravenous ketamine 2 mg/kg (max 60 mg) over 2 minutes (diluted with isotonic saline to 5 mg/ml concentration)

DRUG

Midazolam

Intravenous midazolam 0.2 mg/kg (maximum 10 mg) over 2 minutes

DRUG

Placebo

Intravenous isotonic saline 0.4 ml/kg (max 12 ml) over 5 minutes

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Abdelrahim A Sadek, MD, PhD · Faculty of Medicine, Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-08-26
Completion
2024-08-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779657 on ClinicalTrials.gov