NCT03813277

Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU

Open Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Dexdor for Sedation in Paediatric Patients in Intensive Care Settings. Multi-centre Trial in Russia for Marketing Registration of Dexdor.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor

Detailed description

Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports. Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation. Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.

Conditions

• ICU Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	infusion

Timeline

• Start date: 2017-03-21
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2019-01-23
• Last updated: 2019-01-23

Locations

1 site across 1 country: Russia