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Comparison of two anticonvulsant drugs (rectal diazepam and intramuscular midazolam) in controlling pediatrics seizure

Comparison of the effects of rectal diazepam and intramuscular midazolam in controlling convulsionsin the pediatrics emergency

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170216032603N3
Enrollment
160
Registered
2025-05-12
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

seizure. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group: intramuscular midazolam. Intervention 2: Control group: rectal diazepam.

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 14 Years

Inclusion criteria

Inclusion criteria: Children between one month and 14 years old Seziure

Exclusion criteria

Exclusion criteria: Children with IV line at admission Children who received two dose of benzodiazepines before admission and after seizure Children, who their parents had not consent to participate in study Children who had allergy to rectal diazepam or intramuscular midazolam Children who received even one dose of benzodiazepine before admission Status seizure resistant to treatment Patients who had specific reason for seizure like hypoglycemia, hyponatremia, hypocalcemia and other reasons.

Design outcomes

Primary

MeasureTime frame
The initial consequence of nerve disruption is the cessation of all movements and the absence of their repetition for up to 60 minutes. Timepoint: The duration of seizure control in ranges of less than 5, 10, 30, and 60 minutes and more than 60 minutes is important, not at the level of seconds. Method of measurement: By a stopwatch by trained personnel.

Secondary

MeasureTime frame
?Drug reactions. Timepoint: Less than then miutes, 30 minutes, 4 hour, 6 hour. Method of measurement: Patients examination and checking vital sign by pediatrics resident.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi MontazerLotfollahi

Karaj University of Medical Sciences

hmontazer.hadi@yahoo.com026-32527575-6

Outcome results

None listed

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