UnknownNot Applicable

Evaluating the Effects of Propofol vs. Dexmedetomidine

United States60 participantsStarted 2018-07-24

Plain-language summary

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.)

Who can participate

Age range

3 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedural times to achieve optimal sedation

Timeframe: Start of procedure to discharge (up to 8 hours)

Trial details

NCT IDNCT03552146

SponsorChildren's Healthcare of Atlanta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09-30

Contact for this trial

David Fagin, MD

404-785-6000 david.fagin@pema.com

View on ClinicalTrials.gov More Sedative Adverse Reaction trials