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

Summary

This is a Phase IV open-labeled, multi-center study evaluating the safety of
dexmedetomidine (DEX) when used for sedation of pediatric subjects requiring
non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) in
an intensive care unit, operating room, or in a procedure room with an
intensivist, anesthesiologist or dental anesthesiologist in attendance for an
elective surgical procedure or diagnostic procedure.
An estimated 90 subjects representing three age groups and three populations
will be enrolled.
Age groups:
1. ≥28 weeks gestational age to and amp;lt;3 years;
2. ≥3 years to and amp;lt;12 years;
3. ≥12 years to and amp;lt;17 years
Procedural populations:
1. Non-invasive diagnostic/therapeutic procedures: including ultrasound (US),
computed tomography (CT) scans, magnetic resonance imaging (MRI), cardiac
catheterization or transthoracic echocardiogram (TTE)
2. Minimally invasive diagnostic/therapeutic procedures: including minimally
invasive procedures performed under US or CT guidance (e.g. US or CT-guided
solid organ biopsy), and routine myocardial biopsies in cardiac transplant
recipients;
3. Surgical procedures: including small surgical procedures (e.g. excisions, biopsies)
and dental procedures (e.g. extractions, pulpectomy, pediatric rehabilitation dental
procedures, filings and crowns).
Enrollment will be competitive across the 3 age groups and 3 procedural
populations. A minimum of 25 subjects are to be enrolled per each age group
and 25 subjects are to be enrolled in each procedural population. It is estimated
that the drop out rate will be approximately 10%, thereby 90 subjects (stratified
as 30 per age group and 30 per procedural population) will be enrolled to allow
80 subjects evaluable. The duration of the study will be approximately 45 days
including screening and a 30 day collection period of reported SAEs.

Participant Eligibility

1. Subject is ≥ 28 weeks gestational age and <17 years of age.
Preterm subjects ≥28 weeks through < 38 weeks, gestational age;
Note: Gestational age will be calculated as the time elapsed between the first day
of the last menstrual period to the day of enrollment. If pregnancy was achieved
using assisted reproductive technology, gestational age will be calculated by
adding 2 weeks to the gestational age as calculated above.

2. Subject is American Society of Anesthesiologists (ASA) Physical Status I, II or III.

3. Subject requires non-intubated, spontaneous breathing, moderate to deep sedation,
(NI-MDS) in an operating or procedure room with an intensivist, anesthesiologist or
dental anesthesiologist in attendance.

4. Scheduled for an elective procedure that falls into one of the following three
populations:
Non-invasive diagnostic/therapeutic procedures: including ultrasound (US),
computed tomography (CT) scans, magnetic resonance imaging (MRI), cardiac
catheterization, transthoracic echocardiogram (TTE);
Minimally invasive diagnostic/therapeutic procedures: including minimally
invasive procedures performed under US or CT guidance (e.g. US or CT-guided
solid organ biopsy), and routine myocardial biopsies in cardiac transplant
recipients;
Surgical procedures: including small surgical procedures (e.g. excisions, biopsies)
and dental procedures (e.g. extractions, pulpectomy, pediatric rehabilitation dental
procedures, filings and crowns).

5. Duration of the procedure is expected to take at least 30 minutes to complete.

6. If female, subject is non-lactating and is either:
a. Not of childbearing potential, defined as pre-menarche, or surgically
sterile due to bilateral tubal ligation, bilateral oophorectomy or
hysterectomy.
b. Of childbearing potential but is not pregnant at time of baseline and is
practicing one of the following methods of birth control: oral or parenteral
contraceptives, double-barrier method, vasectomized partner, or
abstinence from sexual intercourse.

7. Subject's parent(s) or legally acceptable representative(s) has/have voluntarily
signed and dated the informed consent document approved by the Institutional
Review Board. Assent will be obtained where age-appropriate and according to
state regulations.