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.
Overview
- Phase
- Phase 3
- Intervention
- Dexmedetomidine
- Conditions
- Dexmedetomidine
- Sponsor
- King Abdullah International Medical Research Center
- Enrollment
- 430
- Locations
- 1
- Primary Endpoint
- Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Dexmedetomidine (D)
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Intervention: Dexmedetomidine
Midazolam (M)
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Intervention: Midazolam
Outcomes
Primary Outcomes
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
Time Frame: from end of sedation to extubation assessed up to 24 hrs
Secondary Outcomes
- To compare length of PICU stay in both groups(from Intubation to discharge assessed up to 1 month)