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

Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Seizures
• Intervention / Treatment: Drug: Buccal midazolam; Drug: Intramuscular midazolam

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Hamad medical corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buccal midazolam; Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg	Drug: Buccal midazolam; Study subject will receive Buccal midazolam, Intramuscular placebo.
Active Comparator: intramuscular midazolam; Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.	Drug: Intramuscular midazolam; Study subject will receive Intramuscular midazolam,Buccal placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cessation of seizure activity five minutes after treatment with study medication.	Cessation of abnormal motor activity with regaining of consciousness.	five minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: September 4, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 14-00050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No