Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
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|ClinicalTrials.gov Identifier: NCT02897856|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Seizures||Drug: Buccal midazolam Drug: Intramuscular midazolam||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Cessation of seizure activity five minutes after treatment with study medication. [ Time Frame: five minutes ]Cessation of abnormal motor activity with regaining of consciousness.
- Major side effects. [ Time Frame: 2 hours after cessation of seizures. ]
- Duration of seizure. [ Time Frame: 5 minutes ]
- Recurrence of seizure activity within one hour after treatment with study medication. [ Time Frame: one hour ]
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
|Hamad medical corporation|
|Doha, Qatar, 3050|