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

Launched by AIN SHAMS UNIVERSITY · Dec 30, 2022

Keywords

ClinConnect Summary

Recruited patients randomized using previously computer-generated randomization tables prepared by expert statistician. Study was approved by the faculty ethical committee prior to its start and oral informed consent was obtained from the parents. In order to simplify the administration process a reference guide was prepared for doses according to weight for each of the 3 routes.

Two major groups were included (home and ER group) and each were subdivided into 3 groups according to route of administration

Children was randomly assigned to receive treatment with intranasal, intramuscular or...

Gender

ALL

Eligibility 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.