Overview

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 Hospit

Status:
Not yet recruiting

Trial end date:
2023-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

King Abdullah International Medical Research Center

Treatments:

Dexmedetomidine
Midazolam

Criteria

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