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.

Phase 3

Recruiting

• Conditions: Dexmedetomidine; Midazolam; Withdrawal Symptoms; Failure of Extubation
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT05485519
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Study Timeline

• Study Start: 2022-04-21
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine (D)	Dexmedetomidine	Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Midazolam (M)	Midazolam	1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To compare length of PICU stay in both groups	from Intubation to discharge assessed up to 1 month

Trial Locations

Locations (1)

King Abdullah Specialist Children Hospital (KASCH); 🇸🇦 Riyadh, Saudi Arabia