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IRCT2017031529801N3 IRCT 2017-11-05 Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Efficacy of Intramuscular Midazolam versus Rectal Gel Diazepam in controlling status epilepticus in children: A randomized double-blind clinical trial - Efficacy of Intramuscular Midazolam versus Rectal Gel Diazepam in controlling status epilepticus in children: A randomized double-blind clinical trial 2017-05-22 anticipated 68 Complete https://irct.ir/trial/23856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the randomization will be done using a random number table. 3 Status epilepticus in children. 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: 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.
public Saeid Sadeghian
Golestan street, Medical School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8573 s.saeid92@gmail.com; fmedicine@ajums.ac.ir Ahvaz Jundishapur University of Medical Sciences, Medical School scientific Dr Reza Azizi Malamiri
Golestan street, Department of Pediatrics, Golestan Hospital, Ahvaz
Ahvaz Iran (Islamic Republic of) 3311861357 +98 61 3374 3063 Azizi.ramin@gmail.com Ahvaz Jundishapur University of Medical Sciences, Golestan Hospital Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 1 month 16 years Both G40-G47 G40.3 Treatment - Drugs 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 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. 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. Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Approved 2017-07-29 Ethics committee of Ahwaz University of Medical Sciences Golestan street, Shahre Daneshgahi, Vice chancellor for research of Ahwaz University of Medical Sciences, Ahvaz Ahvaz Iran (Islamic Republic of)