Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Exclusion Criteria

• •1. Subjects weight at the time of screening is less than 1000 g.
• •2. Subject has received general anesthesia within 7 days prior to study drug administration.
• •3. Subject has participated in an experimental/investigational drug study within 30 days prior to study drug administration.
• •4. Subject has been exposed to dexmedetomidine within 48 hours prior to study drug administration.
• •5. Subject that has been previously enrolled in this study (DEX-10-16).
• •6. Subject requires endotracheal intubation or laryngeal mask airway (LMA).
• •7. Subject is with neurological conditions that in the opinion of the Investigator will preclude reliable assessment of sedation scoring. Examples include, but are not limited to the following: cerebral palsy, autism, severe mental retardation, etc.
• •8. Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment.
• •9. Subject requires epidural or spinal anesthesia.
• •10. Subject has received treatment with an alpha-2 agonist or antagonist within 14 days prior to study drug administration.
• •11. Subject has a known allergy to dexmedetomidine, midazolam or fentanyl.
• •12. Subject is requiring cardiac catheterization for the purpose of conducting an electrophysiology (EP) evaluation or percutaneous intervention (i.e. angioplasty).
• •13. Subject for whom opiates, benzodiazepines, dexmedetomidine or other alpha-2 agonists are contraindicated.
• •14. Subject has received an IV opioid within one hour, or oral/intramuscular (PO/IM) opioid within four hours, prior to the start of study drug administration.
• •15. Subject has received any pre-induction medication (ie, ketamine, chloral hydrate, benzodiazepines) within 4 hours prior to the start of study drug administration.
• •16. Subject has acute myocardial infarction recently diagnosed by confirmatory laboratory findings within 6 weeks of screening.
• •17. Subject has moderate to severe sleep apnea syndrome.
• •18. Subject has oxygen saturation (SpO2) ≤90% at screening or baseline, except for patients with known cyanotic heart disease undergoing cardiac catheterization.
• •19. Subject has bradycardia immediately before dosing, according to respective age group.
• •* ≥28 weeks to \<1 month: Heart Rate (HR) \<120 beats per minute (bpm)
• •* 1 month to \<3 months: HR \<100 bpm
• •* 3 months to \<6 months: HR \<90 bpm
• •* 6 months to \<1 year: HR \<80 bpm
• •* 1 year to \<2 years: HR \<70 bpm
• •* 2 years to \<6 years: HR \<60 bpm
• •* 6 years to \<12 years: HR \<55 bpm
• •* 12 years to 17 years: HR \<50 bpm;
• •Note: Subject can be reassessed after 5 minutes
• •20. Subject has hypotension immediately before dosing, according to respective age group.
• •* ≥28 weeks to \<1 month: \<60 mmHg (systolic blood pressure \[SBP\])
• •* 1 month to \<12 months: \<70 mmHg (SBP)
• •* 1 year to \<10 years: \<70 + (2 X age in years) mmHg (SBP)
• •* 10 years to 17 years: \<90 mmHg (SBP);
• •Note: Subject can be reassessed after 5 minutes
• •21. Subject has a presence of second-degree or third-degree heart block at screening or baseline. The presence of a temporary or permanent pacemaker will waive this exclusion criterion.
• •22. Subject has acute febrile illness, with a temperature (core or tympanic) ≥38.0°C.
• •23. Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.