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Comparing the time required by intramuscular and intranasal forms of Midazolam in aborting seizure

Comparative study of efficacy of intranasal midazolam versus intramuscular midazolam in control of acute seizures in children in the age group of 6 months to 12 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022749
Enrollment
220
Registered
2020-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention1: Intramuscular Midazolam versus intranasal Midazolam: Comparison of efficacy of single intramuscular Midazolam 0.2mg/kg versuss single dose of intranasal Midazolam at 0.2 mg/kg in abort

Sponsors

Government Medical College and Hospital Aurangabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children in age group of 6 months to 12 years with active seizures without I. V. access 2. Patients with written valid and informed consent obtained from their parents

Exclusion criteria

Exclusion criteria: 1. Child who received emergency treatment for present seizures from elsewhere 2. Child with clinically significant psychiatric disorder 3. Children with upper respiratory tract infection and profuse nasal discharge

Design outcomes

Primary

MeasureTime frame
Abortion of motor component of acute seizure activityTimepoint: Time of abortion of ongoing seizure at 5 min and 10 min

Secondary

MeasureTime frame
- To observe side effects on vital parameters of patients after drug administration (intramuscular and intranasal midazolam) - To observe recurrence of seizure (within 1 hr of administration of drug) - To observe the need for use of second anti-epileptic drug Timepoint: Abortion of ongoing seizure activity at 5 min and 10 min and recurrence of seizure within 60 min and effect on pulse, respiratory rate and blood pressure at 5 min and 10 min.

Countries

India

Contacts

Public ContactDr Amit Tukaram Patil

Department of Paediatrics

pmorekhaire@rediffmail.com9823949519

Outcome results

None listed

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