Combined Ketamine and Midazolam for Generalized Convulsive Status Epilepticus

• Status: Not yet recruiting
• Trial end date: 2024-04-02
• Target enrollment: 0
• Participant gender: All

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, we aim to evaluate the efficacy and safety of ketamine plus midazolam versus midazolam alone as first-line therapy of pediatric GCSE.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Ketamine; Midazolam

Criteria

Inclusion Criteria:

• Age from 6 month to 16 years.

• Generalized convulsive status epilepticus, defined as > 5 minutes of clinically observed continuous or recurrent generalized, tonic-clonic seizure activity without regaining of consciousness.

Exclusion Criteria:

• Failure to obtain informed consent.

• Previous treatment with any antiseizure medication for the presenting seizure episode.

• Hypertension

• Alcohol intake

• Conditions associated with increased intracranial pressure (e.g., central nervous system mass lesions, hydrocephalus)

• Glaucoma

• Known allergy or contraindications to any of the study drugs.

• End-stage kidney disease.

• End stage liver disease

• Arrhythmia, severe heart disease, or pulmonary hypertension.

• Hyperthyroidism

• Pheochromocytoma

• Hypoglycemia or hyperglycemia.

• Inborn errors of metabolism.

• Known or suspected psychiatric disorder.

• Failure to obtain intravenous access in the first 5 minutes of stabilization phase.

• Cessation of seizures during the stabilization phase (0 - 5 minutes).

• Traumatic brain injury.