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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897856
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
DR. KHALID AL-ANSARI, 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.

Condition or disease Intervention/treatment Phase
Seizures Drug: Buccal midazolam Drug: Intramuscular midazolam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Major side effects. [ Time Frame: 2 hours after cessation of seizures. ]
  2. Duration of seizure. [ Time Frame: 5 minutes ]
  3. Recurrence of seizure activity within one hour after treatment with study medication. [ Time Frame: one hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897856


Locations
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Qatar
Hamad medical corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
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Responsible Party: DR. KHALID AL-ANSARI, Senior consultanat, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02897856    
Other Study ID Numbers: 14-00050
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action