a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
NCT ID: NCT04356638
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2021-10-17
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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The sedative pre-medication oral Midazolam
Midazolam
Oral Midazolam and intranasal placebo
The sedative pre-medication intranasal Dexmedetomidine
Dexmedetomidine
Intranasal Dexmedetomidine and oral placebo
Placebo
Placebo
Placebo orally and intranasally
No Sedative Pre-medication
No interventions assigned to this group
Interventions
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Midazolam
Oral Midazolam and intranasal placebo
Dexmedetomidine
Intranasal Dexmedetomidine and oral placebo
Placebo
Placebo orally and intranasally
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergies to the study drug
* Refused to take the study drug
* Severe learning disability
* Patient on Digoxin medication
* Patient on beta-blocker medication
* Cardiac disease with abnormal conduction system
* Nasal anatomical abnormality
12 Months
12 Years
ALL
No
Sponsors
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King Faisal Specialist Hospital & Research Center
OTHER
Responsible Party
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Ganesh Sivasankara
Consultant, Anesthesiology
Principal Investigators
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Ganesh Sivasankara, MBBS
Role: PRINCIPAL_INVESTIGATOR
King Faisal Specialist Hospital & Research Center
Locations
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King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2191310
Identifier Type: -
Identifier Source: org_study_id