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

Primary Purpose

Seizures

Status
Completed
Phase
Phase 4
Locations
Qatar
Study Type
Interventional
Intervention
Buccal midazolam
Intramuscular midazolam
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

6 Months - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hamad medical corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Buccal midazolam

intramuscular midazolam

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major side effects.
Duration of seizure.
Recurrence of seizure activity within one hour after treatment with study medication.

Full Information

First Posted
September 4, 2016
Last Updated
July 23, 2019
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02897856
Brief Title
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
Official Title
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buccal midazolam
Arm Type
Active Comparator
Arm Description
Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg
Arm Title
intramuscular midazolam
Arm Type
Active Comparator
Arm Description
Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Buccal midazolam
Intervention Description
Study subject will receive Buccal midazolam, Intramuscular placebo.
Intervention Type
Drug
Intervention Name(s)
Intramuscular midazolam
Intervention Description
Study subject will receive Intramuscular midazolam,Buccal placebo
Primary Outcome Measure Information:
Title
Cessation of seizure activity five minutes after treatment with study medication.
Description
Cessation of abnormal motor activity with regaining of consciousness.
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
Major side effects.
Time Frame
2 hours after cessation of seizures.
Title
Duration of seizure.
Time Frame
5 minutes
Title
Recurrence of seizure activity within one hour after treatment with study medication.
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Hamad medical corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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