Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Buccal midazolam
- Conditions
- Seizures
- Sponsor
- Hamad Medical Corporation
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Cessation of seizure activity five minutes after treatment with study medication.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
DR. KHALID AL-ANSARI
Senior consultanat
Hamad Medical Corporation
Eligibility Criteria
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
- •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
Arms & Interventions
Buccal midazolam
Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg
Intervention: Buccal midazolam
intramuscular midazolam
Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.
Intervention: Intramuscular midazolam
Outcomes
Primary Outcomes
Cessation of seizure activity five minutes after treatment with study medication.
Time Frame: five minutes
Cessation of abnormal motor activity with regaining of consciousness.
Secondary Outcomes
- 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)