Efficacy of Intramuscular Midazolam versus Rectal Gel Diazepam in controlling status epilepticus in children: A randomized double-blind clinical trial

Phase 3

• Conditions: Status epilepticus in children.; G40.3; G40-G47

• Registration Number: IRCT2017031529801N3
• Lead Sponsor: Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.