A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic andPharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged12 months through <24 months

Phase 1

• Conditions: intubated and mechanically ventilated pediatric subjects that require sedation inan 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-000407-24-Outside-EU/EEA
• Lead Sponsor: Hospira Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Subject is 12 months to < 24 months of age at screening.
2. Subject is intubated and mechanically ventilated in an intensive care setting and is
anticipated to require a minimum of 6 hours of continuous IV sedation.
3. Subject has adequate renal function, defined as:
• Serum creatinine = 1.0 mg/dL
4. The subject’s parent(s) or legal guardian(s) must voluntarily sign and date the
informed consent document approved by the Institutional Review Board.
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified