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Pharmacokinetics of dexmedetomidine in paediatric intensive care patients - DEXPEDICU

Pharmacokinetics of dexmedetomidine in paediatric intensive care patients - DEXPEDICU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005934-59-FI
Enrollment
Unknown
Registered
2008-10-15
Start date
2009-01-07
Completion date
Unknown
Last updated
2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children aged 0 - 11 years admitted to paediatric intensive care unit and planned to be sedated and mechanically ventilated for at least 24 hours. The underlying medical conditions can be various kind of illnesses.

Interventions

Trade Name: Precedex (Dexmedetomidine Hydrochloride) injection Pharmaceutical Form: Injection* INN or Proposed INN: dexmedetomidine hydrochloride Concentration unit: µg/ml microgram(s)/millilitre Conc

Sponsors

Kaija Puhakka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 0 - 11 years admitted to paediatric intensive care unit and planned to be sedated and mechanically ventilated for at least 24 hours. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Gestational age less than 37 weeks. Unstable haemodynamics. Defect in cardiac conduction. Contraindication for morphine or dexmedetomidine.

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026