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)

King Abdullah International Medical Research Center

Status and phase: Enrolling; Phase 3

Conditions: Failure of Extubation; Withdrawal Symptoms; Dexmedetomidine; Midazolam

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05485519

RC20/160/R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Dexmedetomidine (D)

Experimental group

Description:

Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)

Treatment:

Drug: Dexmedetomidine

Midazolam (M)

Active Comparator group

Description:

1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.

Treatment:

Drug: Midazolam