Dexmedetomidine Clinical Trial
— PROMISEOfficial title:
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 (PICU) at KASCH-MNGHA.
NCT number | NCT05485519 |
Other study ID # | RC20/160/R |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 21, 2022 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 430 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 14 Years |
Eligibility | Inclusion Criteria: 1. Age 1-14 years both male and female who require mechanical ventilation 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: 1. Septic shock and/or multi-organ failure. 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 |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdullah Specialist Children Hospital (KASCH) | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Abdullah International Medical Research Center |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To compare length of PICU stay in both groups | from Intubation to discharge assessed up to 1 month |
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