ICU Sedation Clinical Trial
Official title:
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.
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
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.
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Status | Clinical Trial | Phase | |
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Completed |
NCT02757625 -
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
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Phase 3 |