Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 17
Updated:9/12/2018
Start Date:September 4, 2018
End Date:November 1, 2019
Contact:Daniel S Tsze, MD, MPH
Email:dst2141@cumc.columbia.edu
Phone:212-305-9825

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Clinical Characteristics of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-painful Procedures

Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN
DEX in children undergoing non-painful procedures. This aim will test the working hypothesis
that IN DEX regimens are effective for producing sedation adequate for completion of
non-painful procedures in children.

Specific Aim 2: To describe the temporal characteristics associated with varied regimens of
IN DEX in children undergoing non-painful procedures, such as time to onset of adequate
sedation; time to procedure start; and time from procedure end to meeting discharge criteria.
This aim will test the working hypothesis that IN DEX regimens have temporal characteristics
that are favourable for sedating children for non-painful procedures.

Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in
children undergoing non-painful procedures. This aim will test the working hypothesis that IN
DEX regimens have a low incidence of adverse events.

Dexmedetomidine (DEX) is an alpha-2 receptor agonist with sedative, anxiolytic, and
analgesics properties. DEX has been used extensively for sedation in children to facilitate
different non-painful procedures, such magnetic resonance imaging (MRI), auditory brainstem
response (ABR) tests, and computed tomography (CT) scans. In particular, DEX can be
administered by the intranasal (IN) route. Intranasal administration has the benefits of
being both effective and needle-free, of which the latter makes it less distressing to
children compared to sedatives administered by the intravenous (IV) route. There is a gap of
knowledge, however, regarding the ideal regimen of IN DEX for providing optimal procedural
sedation in children undergoing non-painful procedures. There is a large variation in
practice using IN DEX, both regarding the dose and the use of adjunct medications. It is also
unknown whether regimens should vary based on patient factors such as age. There is no clear
evidence to define best practice when using IN DEX to provide sedation in this population to
achieve the desired outcomes most relevant to clinicians. The rationale of the proposed
investigation is that by conducting an exploratory study to measure clinical outcomes
associated with IN DEX, the investigators can begin to identify trends and differences that
will lay the foundation for randomized clinical trials to identify the ideal regimen for IN
DEX when providing sedation for non-painful procedures. This will then allow the
investigators to compare IN DEX, at its best, to other sedatives so that the sedative and
regimen associated with the best outcomes relevant to sedation of children undergoing
non-painful procedures can be determined.

Inclusion Criteria:

- Children 2 months to 17 years (i.e. before their 18th birthday)

- Child will be receiving intranasal dexmedetomidine as part of their usual medical care

- Child will be undergoing a non-painful medical procedure, which includes (but is not
limited to): MRI, CT scans, ABR/BAER, echocardiograms, and EEGs.

Exclusion Criteria:

- Known allergy to dexmedetomidine

- Known abnormal renal or hepatic function

- Known cardiac conduction abnormality or heart block

- Current use of digoxin or beta-blockers
We found this trial at
10
sites
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: April Hollenbeck, PA-C
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Joanna Paquin, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Nancy Crego, PhD RN
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Carmen Sulton, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Chapel Hill, North Carolina 27614
Principal Investigator: Janey Phelps, MD
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1929 North Main Street
Hanover, New Hampshire 03755
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Hanover, NH
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Amber Rogers, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Raleigh, North Carolina 27610
Principal Investigator: Michelle Davis, RN
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San Jose, California 95128
Principal Investigator: Nicole Baier, MD
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San Jose, CA
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