Status epilepticus in children. G40.3
Conditions
Interventions
Intervention 1: Intervention group 1: Midazolam, a dose of 0.3 mg per kg (maximum 15 mg), intramuscular, along with a placebo rectal gel tube, once when arrival to emergency department. Intervention 2
Treatment - Drugs
Intervention group 1: Midazolam, a dose of 0.3 mg per kg (maximum 15 mg), intramuscular, along with a placebo rectal gel tube, once when arrival to emergency department
Intervention group 2: Diazepam, a dose of 0.5 mg per kg (maximum 10 mg),rectal gel tube,along with intramuscular placebo, once when arrival to emergency department
Sponsors
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Months to 16 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age of one month and up to 16 years, Status epilepticus more than 5 minutes during arrival to emergency department. Exclusion criteria: Having an established IV access on arrival to emergency departments, Use of nasal and rectal benzodiazepines prior arrival to the emergency departments by parents or paramedics, Parents discontent to participate in the study, Serial seizures without recovery of consciousness between seizures, and having a history of serious adverse reactions to IM midazolam or rectal diazepam.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stopping of all motor activity after drug administration without recurrence within 60 min after stopping of seizure. Timepoint: After drug administration until 60 minutes later. Method of measurement: Visual analogue scale and digital chronometer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to cessation after medication. Timepoint: Once and after prescribing the medication. Method of measurement: Digital chronometer.;Time from arrival to administer medication. Timepoint: Once and after prescribing the medication. Method of measurement: Digital chronometer.;Time to cessation after arrival. Timepoint: Once and after prescribing the medication. Method of measurement: Digital chronometer.;Medication side effects. Timepoint: After drug administration. Method of measurement: Monitoring of vital signs and symptoms developed up to 60 minutes after intervention. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Sadeghian
Ahvaz Jundishapur University of Medical Sciences, Medical School
Outcome results
None listed