Optimal initial dose of intravenous midazolam in prolonged convulsive seizures in children.

Comparing two doses of bolus intravenous midazolam (0.1 mg/kg vs 0.2 mg/kg) as first line treatment in patients with convulsive status epilepticus aged 1 month to 18 years for seizure cessation within 5 minutes: A randomized clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103117

Enrollment

104

Registered

2026-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: 0.2mg/kg of intravenous midazolam: 0.2 mg/kg intravenous Midazolam as bolus dose in convulsive status epilepticus in children. If the seizures does not abort in 5 minutes, a repeat dose

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 1 month to 18 years presenting with convulsive status epilepticus

Exclusion criteria

Exclusion criteria: Failure to establish IV access within 5 minutes Neurodegenerative disorder (including epileptic encephalopathy with progressive course), either known or diagnosed later. Cases that have received any IV anti seizure medications in the last 6 hours.

Design outcomes

Primary

Measure	Time frame
In patients with convulsive status epilepticus aged 1 month to 18 years, to compare the proportion of seizure cessation within 5 minutes, post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam Timepoint: In patients with convulsive status epilepticus aged 1 month to 18 years, to compare the proportion of seizure cessation within 5 minutes, post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam	—

Measure

Time frame

In patients with convulsive status epilepticus aged 1 month to 18 years, to compare the proportion of seizure cessation within 5 minutes, post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam Timepoint: In patients with convulsive status epilepticus aged 1 month to 18 years, to compare the proportion of seizure cessation within 5 minutes, post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam

—

Secondary

Measure	Time frame
Time to seizure cessation post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam Adverse events in both arms Conversion rates to refractory, super refractory, and non-convulsive status epilepticus in both arms Timepoint: a)Time to seizure cessation b) Hypotension, need for assisted ventilation within 5 minutes of administration of IV midazolam c) Proportion of patients with refractory, super refractory, and non-convulsive status epilepticus in both arms	—

Measure

Time frame

Time to seizure cessation post first line bolus treatment with 0.2mg/kg IV midazolam compared to 0.1 mg/kg midazolam Adverse events in both arms Conversion rates to refractory, super refractory, and non-convulsive status epilepticus in both arms Timepoint: a)Time to seizure cessation b) Hypotension, need for assisted ventilation within 5 minutes of administration of IV midazolam c) Proportion of patients with refractory, super refractory, and non-convulsive status epilepticus in both arms

—

Countries

India

Contacts

Public ContactDr Biswaroop Chakrabarty

AIIMS DELHI

biswaroopchakrabarty@gmail.com9818260603

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026