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.

King Abdullah International Medical Research Center430 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

430

Conditions

Dexmedetomidine Midazolam Withdrawal Symptoms Failure of Extubation

Eligibility

Sex: ALLMin age: 1 YearMax age: 14 Years

Medical Language ↔ Plain English

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

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

Time frame: from Intubation to discharge assessed up to 1 month