Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
NCT ID: NCT05485519
Last Updated: 2023-04-27
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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UNKNOWN
PHASE3
430 participants
INTERVENTIONAL
2022-04-21
2024-05-31
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
TREATMENT
NONE
Study Groups
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Dexmedetomidine (D)
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Dexmedetomidine
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Midazolam (M)
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Midazolam
(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.
Interventions
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Dexmedetomidine
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Midazolam
(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.
Eligibility Criteria
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Inclusion Criteria
2. Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
3. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
Exclusion Criteria
2. Hemodynamically instability and requires inotropes.
3. Severe intracranial or spinal trauma with high intracranial pressure
4. Liver failure
5. Acute or chronic renal failure.
6. Glasgow Coma Scale (GCS) ≤8
7. Known to have allergy to the study drugs
8. Airway surgery
1 Year
14 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
Responsible Party
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Locations
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King Abdullah Specialist Children Hospital (KASCH)
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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RC20/160/R
Identifier Type: -
Identifier Source: org_study_id
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