Intranasal vs Buccal vs Intramuscular Midazolam for the Home and Emergency Treatment of Acute Seizures

• Status: Completed
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

A randomized controlled clinical trial comparing patient/ ER physician satisfaction and ease of administration of 3 non IV routes of midazolam as a rescue medication for seizure control. Study population included children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home and those presenting to ER with following inclusion and exclusion criteria

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Children aged between 1 months and 17 years

• children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home

• Patients with generalized tonic-clonic status epilepticus with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:

1. Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour

2. Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness

3. Currently presenting with a single seizure (convulsive) lasting >=5 minutes

Exclusion Criteria:

• Any child who had received an anticonvulsant benzodiazepine agent within 1 hour of presentation

• Patients with known history of hypersensitivities, non-responsiveness or contraindications to benzodiazepines (i.e., clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, use of concomitant drugs determined by the investigator to have a contraindication to the use of bbenzodiazepines.)

• Patients with significant hypotension and cardiac dysrhythmia (e.g. atrioventricular block of second or third degree, ventricular tachycardia]).

• Patients with current hypoglycemia (glucose <60 milligram per deciliter [mg/dl]) on presentation at the hospital or healthcare setting.