Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Exclusion Criteria

• •1. Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:
• •* Diminished consciousness from increased intracranial pressure.
• •* The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
• •* Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
• •2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
• •3. Heart rate \<120 bpm prior to the initiation of study drug.
• •4. Exposure to any investigational drug within 30 days prior to study drug administration.
• •5. Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
• •6. Maternal history of poly-substance drug abuse, based upon the presence of 1) an abnormal urine drug screen for cocaine, opiates and/or benzodiazepines; or 2) Investigator's judgment.
• •7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
• •8. Subjects who have a known allergy or contraindication to fentanyl, morphine, Midazolam, DEX, or other α-2 agonists.
• •9. Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
• •10. Screening alanine aminotransferase (ALT) levels \>115 U/L.