NCT02296073

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Anhui Provincial Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

Conditions

• Failed Conscious Sedation During Procedure

Interventions

Type	Name	Description
DRUG	Midazolam	midazolam 3～5μg/kg•min for maintenance of sedation.
DRUG	Dexmedetomidine	Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
DRUG	Dexmedetomidine	Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
DRUG	Dexmedetomidine	Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
DRUG	Fentanyl	Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
OTHER	assessment	Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.

Timeline

• Start date: 2014-12-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2014-11-20
• Last updated: 2014-11-21