Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures

Study Overview
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Brief Summary
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The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.

Detailed Description
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Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects. In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.

Official Title
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Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial

Conditions
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Seizures

Intervention / Treatment
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* Drug: Buccal midazolam
* Drug: Intramuscular midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study. Exclusion Criteria: Cardiac arrest Head trauma Drowning Congenital heart disease Inborn errors of metabolism Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia) Hemodynamic instability Allergy to benzodiazepines Focal seizures with preserved level of consciousness

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buccal midazolam<br>Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg | Drug: Buccal midazolam<br>* Study subject will receive Buccal midazolam, Intramuscular placebo.<br>|
| Active Comparator: intramuscular midazolam<br>Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg. | Drug: Intramuscular midazolam<br>* Study subject will receive Intramuscular midazolam,Buccal placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of seizure activity five minutes after treatment with study medication. | Cessation of abnormal motor activity with regaining of consciousness. | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major side effects. |  | 2 hours after cessation of seizures. | 
| Duration of seizure. |  | 5 minutes | 
| Recurrence of seizure activity within one hour after treatment with study medication. |  | one hour |