Clinical trial NCT03220880: Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Official title: Clinical Characteristics of Intranasal Dexmedetomidine for Sedation in Children Undergoing Non-painful Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dexmedetomidine
Sedation
Keywords: Dexmedetomidine
Sedation
Pediatric
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
name: University of Pittsburgh
name: Children's Hospital Medical Center, Cincinnati
name: UNC Children's Hospital
name: Santa Clara Valley Medical Center
name: Baylor College of Medicine
name: HSHS St. John's Hospital
name: Boston Children's Hospital
First posted: 2017-07-18
Enrollment: 578
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing sedation using intranasal dexmedetomidine for non-painful procedures.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adequacy of sedation
timeFrame: 1 hour
Secondary outcomes:
measure: Time to onset of adequate sedation
timeFrame: 1 hour
measure: Time to discharge
timeFrame: 2 hours
Other outcomes:
measure: Adverse events
timeFrame: 3 hours
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University Healthcare
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Chapel Hill
country: United States
facility: UNC Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Columbia University
name: Daniel S Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: