Evaluating the Effects of Propofol vs. Dexmedetomidine

Status unconfirmed

Conditions studied: Sedative Adverse Reaction

In brief

The primary purpose of this observational study is to compare what drugs work best in sedating children (\> 3 months to \< 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. The investigators are planning to have 60 children complete the study at Children's Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed and approved for the sedation performed for consented patients.)

Key facts

Study ID

NCT03552146

Run by

Children's Healthcare of Atlanta

People needed

60

Starts

2018-07-24

Expected to finish

2019-09-30

Last updated by the study team

2019-07-24

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient (or Parent/Guardian) is English speaking
• Patient is undergoing a scheduled, elective non-contrast MRI of the brain
• Patient is > 3 months to <36 months of age

You may not qualify if…

• Patients undergoing MRI with contrast
• Patients older than 36 months of age or younger than 3 months of age
• Patients presenting to Emergency Department (ED) out of screening hours
• Patients who are not English speaking
• Patients who have history or record of propofol or dexmedetomidine allergy
• Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy based products; if patient has a history of a hypersensitivity reaction associated with exposure to eggs, egg products, soybeans, or soy based products, approval must be given by the treating attending physician and documented on the patient's medical record.
• Patients with unstable cardiac or respiratory status as determined by treating attending physician
• Patients who are receiving digoxin

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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