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.
PROMISE
1 other identifier
interventional
430
1 country
1
Brief Summary
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2022
CompletedFirst Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 27, 2023
April 1, 2023
2 years
June 30, 2022
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
from end of sedation to extubation assessed up to 24 hrs
Secondary Outcomes (1)
To compare length of PICU stay in both groups
from Intubation to discharge assessed up to 1 month
Study Arms (2)
Dexmedetomidine (D)
EXPERIMENTALInfusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Midazolam (M)
ACTIVE COMPARATOR1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Interventions
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Eligibility Criteria
You may qualify if:
- Age 1-14 years both male and female who require mechanical ventilation
- 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.
- Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
You may not qualify if:
- Septic shock and/or multi-organ failure.
- Hemodynamically instability and requires inotropes.
- Severe intracranial or spinal trauma with high intracranial pressure
- Liver failure
- Acute or chronic renal failure.
- Glasgow Coma Scale (GCS) ≤8
- Known to have allergy to the study drugs
- Airway surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdullah Specialist Children Hospital (KASCH)
Riyadh, 14611, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
August 3, 2022
Study Start
April 21, 2022
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
April 27, 2023
Record last verified: 2023-04