NCT05485519

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.

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dexmedetomidine
• Midazolam
• Withdrawal Symptoms
• Failure of Extubation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
DRUG	Midazolam	(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-08-03
• Last updated: 2023-04-27

Locations

1 site across 1 country: Saudi Arabia