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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dexmedetomidine, Midazolam, Withdrawal Symptoms, Failure of Extubation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine (D)<br>Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour) | Drug: Dexmedetomidine<br>* Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)<br>|
| Active Comparator: Midazolam (M)<br>1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute. | Drug: Midazolam<br>* (1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare length of PICU stay in both groups |  | from Intubation to discharge assessed up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating