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

• Status: Completed
• Trial end date: 2018-05-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Dexmedetomidine

Criteria

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 Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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.