Dexmedetomidine and Caffeine for Pediatric MRI Recovery
Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study
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 |
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06538584 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 12 years who are scheduled for an MRI and meet specific health criteria.
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.
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 performed: Previous studies have shown positive outcomes with dexmedetomidine sedation in pediatric populations, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.