ICU Sedation
Conditions
Brief 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
Detailed description
Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports. Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation. Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.
Interventions
DRUGDexmedetomidine
infusion
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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 Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis 10.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients | max 5 days | Time spent in target sedation range (RASS score ) |
| Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients | max 5 days | Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wake-up/discontinuation of sedation (if applicable) | max 5 days | Wake-up/discontinuation of sedation (if applicable) |
| Time to extubation. | max 5 days | Extubation assessment (if applicable). |
| Time to first rescue medication | max 5 days | Time to first rescue medication |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | max 5 days | Clinical safety of dexdor infusion |
Countries
Russia
Outcome results
None listed