Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures

Completed

Conditions studied: Dexmedetomidine, Sedation

In brief

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.

Key facts

Study ID

NCT03220880

Run by

Columbia University

People needed

578

Starts

2018-09-04

Expected to finish

2020-01-31

Last updated by the study team

2021-09-10

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy to dexmedetomidine
• Known abnormal renal or hepatic function
• Known cardiac conduction abnormality or heart block
• Current use of digoxin or beta-blockers

Where it is running

• Santa Clara Valley Medical Center — San Jose, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Southern Illinois University Healthcare — Springfield, Illinois, 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
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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