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Comparing buccal midazolam vs. intravenous diazepam in control of acute seizures in children.

Comparing buccal midazolam vs. intravenous diazepam in control of acute seizures in children: a randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138902293967N1
Enrollment
92
Registered
2011-08-14
Start date
2007-12-24
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute childhood seizure. Epilepsy

Interventions

Intervention 1: Intervention group1: after establishing an intravenous route diazepam is infused 0.2-0.3 mg/kg to control seizure. Intervention 2: Intervention group2: buccal midazolam is administer
Treatment - Drugs
Intervention group1: after establishing an intravenous route diazepam is infused 0.2-0.3 mg/kg to control seizure
Intervention group2: buccal midazolam is administered to children with convulsion based upon the age as follow: 2.5 mg for children aged 6-12 months 5mg for children 1-4 years 7.5 mg for children5-9 y

Sponsors

Pediatric Neurology Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all children aged 6 months to 14 years old presenting with acute generalized seizure in emergency ward or pediatric neurology ward are randomly assigned to receive buccal midazolam or intravenous diazepam. Exclusion criteria: seizures due to head trauma or known metabolic causes (hypoglycemia, hypocalcemia)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The time it takes to control seizure. Timepoint: The time it takes to control seizure is measured once after using IV diazepam vs. buccal midazolam. Method of measurement: Time measured in minute, evaluated from start to the end of seizure.

Secondary

MeasureTime frame
Potential side effects. Timepoint: Potential side effects of the two drugs. Method of measurement: Clinical evaluation of possible side effect.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Hassan Tonekaboni

Pediatric Neurology Research Center

tonekaboni@sbmu.ac.ir; shtonekaboni@yahoo.com+98 21 2290 9559

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026