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New treatment option for Enhanced Recovery After Surgery in a Pediatric Population
Official title Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
ClinicalTrials.gov ID: NCT06538584
What this study is testing
What is Caffeine citrate 15mg/kg?
Caffeine citrate 15mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for enhanced recovery after surgery in a pediatric population.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Age \ 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
See the full eligibility 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
- Age \ 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 people who are pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.