Status:
COMPLETED
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
ICU Sedation
Eligibility:
All Genders
12-17 years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- Age from 12 to 17 years;
- Clinical need for prolonged (\>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
- Negative urine pregnancy test (for female patients);
- Written informed consent
Exclusion
- 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;
- Uncompensated acute circulatory failure;
- Severe hypotension or hypertension
- Severe bradycardia or tachycardia
- A/V-conduction block II-III;
- Severe hepatic impairment
- Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data;
- Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation;
- Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- Patients receiving sedatives for therapeutic indications (e.g. epilepsy);
- Patients allergic to dexmedetomidine and rescue medications
- Hemodialysis and peritoneal dialysis;
- Those requiring deep sedation or neuromuscular blocking agents;
- Burn injuries and other injuries requiring regular anaesthesia or surgery;
- History / family history of malignant hyperthermia;
- Patients unlikely to be weaned from the ventilator during the study;
- Patients with early-onset ventilator-associated pneumonia;
- Any investigational drug within the preceding 30 days;
- Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study.
Key Trial Info
Start Date :
March 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03813277
Start Date
March 21 2017
End Date
May 21 2018
Last Update
January 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
State Federal-Funded Educational Institution of
Moscow, Russia, 117997