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

Phase 4

Completed

• Conditions: Seizures
• Interventions: Drug: Intramuscular midazolam; Drug: Buccal midazolam

• Registration Number: NCT02897856
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intramuscular midazolam	Intramuscular midazolam	Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.
Buccal midazolam	Buccal midazolam	Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg

Primary Outcome Measures

Name	Time	Method
Cessation of seizure activity five minutes after treatment with study medication.	five minutes	Cessation of abnormal motor activity with regaining of consciousness.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hamad medical corporation; 🇶🇦 Doha, Qatar