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

ICU Sedation Clinical Trial

— Pedrux  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813277
• Other study ID #: 3005031
• Status: Completed
• Phase: Phase 4
• Start date: March 21, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: January 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• ICU Sedation

Intervention

Drug:
• Dexmedetomidine
infusion

Locations

Country	Name	City	State
Russian Federation	State Federal-Funded Educational Institution of	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability	Clinical safety of dexdor infusion	max 5 days
Primary	Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients	Time spent in target sedation range (RASS score )	max 5 days
Primary	Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients	Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)	max 5 days
Secondary	Wake-up/discontinuation of sedation (if applicable)	Wake-up/discontinuation of sedation (if applicable)	max 5 days
Secondary	Time to extubation.	Extubation assessment (if applicable).	max 5 days
Secondary	Time to first rescue medication	Time to first rescue medication	max 5 days