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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-11-30

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.

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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.

Conditions

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Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Buccal midazolam

Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg

Group Type ACTIVE_COMPARATOR

Buccal midazolam

Intervention Type DRUG

Study subject will receive Buccal midazolam, Intramuscular placebo.

intramuscular midazolam

Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.

Group Type ACTIVE_COMPARATOR

Intramuscular midazolam

Intervention Type DRUG

Study subject will receive Intramuscular midazolam,Buccal placebo

Interventions

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Buccal midazolam

Study subject will receive Buccal midazolam, Intramuscular placebo.

Intervention Type DRUG

Intramuscular midazolam

Study subject will receive Intramuscular midazolam,Buccal placebo

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No