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

Hamad Medical Corporation (HMC)

Status and phase: Completed; Phase 4

Conditions: Seizures

Treatments: Drug: Buccal midazolam; Drug: Intramuscular midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02897856

14-00050

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Buccal midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Buccal midazolam

intramuscular midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Intramuscular midazolam