Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure

Ghent University Hospital (UZ)

Status and phase

Terminated

Phase 3

Conditions

Respiratory Failure

Treatments

Procedure: blood sampling

Drug: dexmedetomidine

Procedure: Vital signs

Study type

Interventional

Funder types

Other

Identifiers

NCT01076816

2009/518

Details and patient eligibility

About

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Enrollment

1 patient

Sex

All

Ages

1 month to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients (m/f) admitted to the paediatric intensive care unit
expected to require at least 24h of mechanical ventilation
patient age : 1 month-15 years
patients with single-organ respiratory failure

Exclusion criteria

patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
no arterial catheter in place at inclusion
patients who have received another investigational drug within 30 days
patients on continuous infusion with neuromuscular blockers
patients with a life expectancy <72h
patients with a known allergy to lorazepam, midazolam and/or morphine
heart block
pre-existing bradycardia
hemodynamically unstable patients (Wernovsky index > 16 points) after full fluid replacement with crystalloid
patients with significant renal insufficiency (creatinine plasma level 1 month-5 year : > 1 mg/dl ; 5-10 years : >1.2 mg/dl; > 10 years : > 1.5 mg/dl)
patients with significant hepatic insufficiency (aspartate aminase >950 UI/L and prothrombin time < 60 or INR >1.4)
previous treatment with α2-adrenoreceptor agonist clonidine within 14 days