Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220880
• Other study ID #: AAAR5010
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexmedetomidine
• Sedation

Intervention

Drug:
• Intranasal dexmedetomidine
Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	UNC Children's Hospital	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Southern Illinois University Healthcare	Springfield	Illinois

Sponsors (9)

Lead Sponsor	Collaborator
Columbia University	Baylor College of Medicine, Boston Children's Hospital, Children's Healthcare of Atlanta, Children's Hospital Medical Center, Cincinnati, HSHS St. John's Hospital, Santa Clara Valley Medical Center, UNC Children's Hospital, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events and/or required interventions (e.g. cardiovascular, airway) required	3 hours
Primary	Adequacy of sedation	Pediatric Sedation State Scale	1 hour
Secondary	Time to onset of adequate sedation	Time in minutes after administration of IN DEX to achieve a University of Michigan Sedation Scale (UMSS) score of 3 or more	1 hour
Secondary	Time to discharge	Time in minutes after procedure end to achieving Modified Aldrete Scoring System (MASS) score of 9 or greater, or baseline MASS score.	2 hours