Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

Exclusion Criteria

• •Pediatric subjects with neurological conditions that prohibit an evaluation of sedation
• •* Diminished consciousness from increased intracranial pressure.
• •* Extensive brain surgery (surgery requiring intracranial pressure monitor).
• •* Diminished cognitive function per PI's discretion.
• •* Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking agents.
• •Weight \<10 kg.
• •Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires.
• •Hepatic impairment Serum glutamic pyruvic transaminase/Alanine aminotransferase (SGPT/ALT) \>100 U/L
• •Hypotension based on repeat assessments prior to starting study drug:
• •* Age ≥2 years old through ≤12 years old: systolic blood pressure (SBP) \<80 mmHg
• •* Age \>12 years old through \<17 years old: SBP \<90 mmHg
• •Pre-existing bradycardia prior to starting study drug defined as:
• •* Age ≥2 years old through ≤6 years old: ≤70 beats per minute (bpm)
• •* Age \>6 years old through ≤12 years old: ≤60 bpm
• •* Age \>12 years old through ≤16 years old: ≤50 bpm
• •Acute thermal burns involving more than 15 percent total body surface area.
• •Subjects who have a known allergy to dexmedetomidine, midazolam (MDZ) or fentanyl.
• •Subjects with a life expectancy that is \<72 hours.
• •Subjects that are expected to have hemodialysis (continuous hemofiltration) or peritoneal dialysis within 48 hours.
• •Subjects who have been treated with α-2 agonists/antagonists within two weeks.
• •Subjects with a spinal cord injury above T5.
• •Subjects who have received another investigational drug within the past 30 days.
• •Subjects on nicotine replacement therapy.
• •Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.