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

Hamad Medical Corporation150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Seizures

Interventions

Buccal midazolamDRUG

Study subject will receive Buccal midazolam, Intramuscular placebo.

Intramuscular midazolamDRUG

Study subject will receive Intramuscular midazolam,Buccal placebo

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Hamad medical corporation

Doha, Qatar

Outcomes

Primary Outcomes

Cessation of seizure activity five minutes after treatment with study medication.

Cessation of abnormal motor activity with regaining of consciousness.

Time frame: five minutes

Secondary Outcomes

Major side effects.

Time frame: 2 hours after cessation of seizures.

Duration of seizure.

Time frame: 5 minutes

Recurrence of seizure activity within one hour after treatment with study medication.

Time frame: one hour

Data from ClinicalTrials.gov

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