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

Inclusion Criteria: 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 Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis 10.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.