Dexmedetomidine and Caffeine for Pediatric MRI Recovery
Official title: Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study
Run by University of Chicago · NCT06538584 · Data updated 2026-11-12
This study tests whether adding caffeine to a sedation medicine can help children aged 3 to 12 recover faster and have fewer problems after getting an MRI.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | July 1, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT06538584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 12 years who are scheduled for an MRI and meet specific health criteria.
✕Probably not a fit
Patients outside the age range of 3 to 12 years or those with certain medical histories, such as arrhythmias or congenital heart disease, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effects of dexmedetomidine sedation with and without caffeine citrate in pediatric patients undergoing MRI scans. The study aims to improve recovery times and reduce complications associated with sedation in children aged 3 to 12 years. Participants will be monitored for vital signs and sedation levels, and the study will assess the impact of caffeine on recovery duration and overall patient outcomes. The trial involves a single pre-sedation visit and the administration of study drugs on the day of the MRI procedure.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery times and improve the overall experience for pediatric patients undergoing MRI procedures.
How similar studies have gone: Previous studies have shown positive outcomes with dexmedetomidine sedation in pediatric populations, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergo Magnetic Resonance Imaging (MRI) scan * Age ≥3 and ≤ 12 yr old * Both Male and Female * Weight ≤33.3 kg * American Society of Anesthesiologists ASA) physical status 1-3 * No History of Arrhythmia (3-leads Electrocardiogram \[EKG\] applied before and after the sedation) or congenital heart disease * Capable of obtaining consent from at least one parent * No history of liver and kidney impairment * No history of head trauma * No prior history of difficulty with anesthesia * No personal or family history of malignant hyperthermia Exclusion Criteria: * Age \<3 or \>12 * Weight \>33.3 kg * ASA physical status \> 3 * History Arrhythmia, congenital heart disease, liver, and kidney diseases * Prior difficulty with anesthesia * Personal or family history of malignant hyperthermia * Unable to obtain consent * History of head trauma * Female subjects who are pregnant
Where it's running
-
University of Chicago Medical Center
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Zheng Xie, MD,PhD — University of Chicago
- Study coordinator: Zheng Xie, MD, PhD
- Email: jxie@bsd.uchicago.edu
- Phone: 773-702-2667
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.