intubated and mechanically ventilated pediatric subjects that require sedation in an intensive care setting for a minimum of 6 hours but not to exceed 24 hours. Subjects eligible for enrollment are 12 months to < 24 months of age
Conditions
Interventions
Trade Name: Precedex
Product Name: dexmedetomidine HCl
Pharmaceutical Form: Concentrate for solution for injection/infusion
Sponsors
Hospira Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is 12 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pediatric subjects with neurological conditions that prohibit an evaluation of sedation such as: • Diminished consciousness from increased intracranial pressure • Extensive brain surgery (surgery requiring intracranial pressure monitor) • Diminished cognitive function per Principal Investigator (PI) discretion • Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking agents. 2. Subjects with second degree or third degree heart block unless subject has a permanent pacemaker or pacing wires are in situ. 3. Subjects who have hepatic impairment as defined by a SGPT/ALT >90 U/L at the time of Screening. 4. Subjects who have hypotension, based on repeat assessments within 15 minutes preceding the start of study drug, defined as: • SBP < 70 mmHg 5. Pre-existing bradycardia based on repeated assessments within 15 minutes preceding the start of study drug, defined as: • HR < 70 bpm 6. Subject who have acute thermal burns involving more than 15 percent total body surface area. 7. Subjects who have a known allergy to dexmedetomidine, MDZ or fentanyl. 8. Subject who has received dexmedetomidine within 24 hours prior to the start of study drug. 9. Subjects with a life expectancy that is < 72 hours. 10. Subjects that are expected to have hemodialysis (continuous hemofiltration), peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments within 48 hours prior to the start of study drug or during the duration of the study. 11. Subjects who have been treated with a-2 agonists/antagonists within two weeks (see Appendix B). 12. Subjects with a spinal cord injury above T5. 13. Subjects who have received another investigational drug as part of an investigational drug study within the past 30 days. 14. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the pharmacokinetic (PK) profile of dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in pediatric subjects 12 months through <24 months of age. 2. To define the pharmacodynamic (PD) profile of dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in pediatric subjects 12 months through <24 months of age.;Secondary Objective: To evaluate safety in subjects 12 months through <24 months of age;Primary end point(s): To define the pharmacokinetic (PK) profile of dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in pediatric subjects 12 months through < 24 months of age. 2. To define the pharmacodynamic (PD) profile of DEX administered as an IV loading dose followed by a continuous IV infusion in pediatric subjects 12 months through < 24 months of age;Timepoint(s) of evaluation of this end point: Each subject received a loading dose of DEX over 10 minutes followed by the appropriate continuous infusion maintenance dose of DEX for a minimum of 6 but not more than 24 hours (including the loading dose time). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety of DEX in subjects 12 months through < 24 months of age.;Timepoint(s) of evaluation of this end point: Each subject received a loading dose of DEX over 10 minutes followed by the appropriate continuous infusion maintenance dose of DEX for a minimum of 6 but not more than 24 hours (including the loading dose time). | — |
Countries
United States
Contacts
Public ContactGlobal Clinical R&D and Medical Af
Hospira Inc
Outcome results
None listed