drugset / Trial / NCT04885075

Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in Children

NCT04885075

RandomizedParallel-groupOpen-labelTreatment

Summary

After approval , study will be conducted at the Children Hospital PIMS, Islamabad. Children 1-12 years presenting/admitted with seizures will be enrolled in the study after taking informed consent from the parents. Children's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive single dose of intravenous diazepam (0.2mg/kg/dose)after passing cannula, while Group B (GB) will receive single dose of intranasal midazolam (0.2mg/kg/dose).Response to treatment will be assessed by recording the time required for termination of seizures in both gruops.the time required for gaining intravenous accessin Group A will be recorded as well. Data will be collected through a structured performa.

Timeline

Start
2021-05-30
Primary completion
2021-11-30
Completion
2021-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Diazepam Small molecule 0.2 mg/kg Intravenous
Subject Midazolam Small molecule 0.2 mg/kg Intranasal

Indications