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

1. Age from 12 to 17 years;
2. Clinical need for prolonged (>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
3. Negative urine pregnancy test (for female patients);
4. Written informed consent

Exclusion Criteria:

1. Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury; any other disorder where sedation assessment is not reliable due to any neurological conditions;
2. Uncompensated acute circulatory failure;
3. Severe hypotension or hypertension
4. Severe bradycardia or tachycardia
5. A/V-conduction block II-III;
6. Severe hepatic impairment
7. Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data;
8. Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation;
9. Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
10. Patients receiving sedatives for therapeutic indications (e.g. epilepsy);
11. Patients allergic to dexmedetomidine and rescue medications
12. Hemodialysis and peritoneal dialysis;
13. Those requiring deep sedation or neuromuscular blocking agents;
14. Burn injuries and other injuries requiring regular anaesthesia or surgery;
15. History / family history of malignant hyperthermia;
16. Patients unlikely to be weaned from the ventilator during the study;
17. Patients with early-onset ventilator-associated pneumonia;
18. Any investigational drug within the preceding 30 days;
19. Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study.