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Comparison of ketamine and midazolam in management of refractory status epilepticus in children.

Ketamine vs midazolam in pediatric refractory status epilepticus: an open label randomized controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069791
Enrollment
40
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: G408- Other epilepsy and recurrent seizures

Interventions

Intervention1: Midazolam: Bolus of Inj. Midazolam IV (0.2mg/kg) up to 10mg followed by infusion of 0.2mg/kg/hr and increasing the infusion rate every 15 mins by 0.05mg/kg/hr till max 2mg/kg/hr or

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children presenting in the Department of Paediatrics fulfilling the criteria for refractory status epilepticus in the age group of 1 month to 12 years.

Exclusion criteria

Exclusion criteria: Patients presenting with Traumatic Brain Injury. Known allergy or anaphylaxis due to Ketamine or Midazolam. Children presenting with stage 2 hypertension i.e., more than 95th centile plus 12mmHg.

Design outcomes

Primary

MeasureTime frame
Proportion of children of refractory status epilepticus attaining clinical seizure control on IV ketamine infusion vs IV midazolam infusion within 24 hours of initiation of infusion in the two groups. Timepoint: 24 hours

Secondary

MeasureTime frame
Proportion of children failing to achieve clinical seizure control and requiring additional anti-epileptic drugs.Timepoint: 24 hours;Proportion of patients having recurrence of seizure after tapering the infusion within 24 hours.Timepoint: 24 hours;Time required to attain clinical seizure control in two groups using ketamine or midazolam.Timepoint: Not defined

Countries

India

Contacts

Public ContactRahul Mahendwaria

Maulana Azad Medical College

drvkumar1@gmail.com9313985662

Outcome results

None listed

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