Children's Mercy Hospital Kansas City
The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI
Anesthesia
Dexmedetomidine
General anesthetic
PHASE1
MRI is an important and robust medical imaging technique that has become the cornerstone for radiologic studies. Superior image quality and resolution especially for soft tissue imaging, without the use of ionizing radiation has made MRI one of the most dominant imaging modalities in pediatrics. Despite its many advantages, MRI is not child friendly. Lengthy scan times, the need for lying motionless in a confined space, excessive noise and vibration during image acquisition, are all factors that have made anesthesia an integral part of pediatric MRI. General anesthesia is a state of medically induced unconsciousness, analgesia and muscle relaxation which is required for most invasive medical procedures. Despite being painless, imaging tests such as MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative patients such as pediatrics. While very safe, general anesthesia carries potential risk of serious morbidity and mortality secondary to aspiration during instrumentation of the airway, hypoxia and hypoventilation secondary to laryngospasm/bronchospasm and hemodynamic instability. Therefore, sedation may be an appropriate technique to offer anxiolysis, amnesia and immobility while maintaining airway reflexes with limited impact on ventilation and hemodynamics for non-stimulating procedures such as imaging. Aside from having a more favorable risk/benefit profile compared to general anesthesia when it comes to radiologic studies, sedation is also less costly and burdensome on anesthesia departments and could provide immense cost-saving measures for healthcare institutions at large. While there are many intravenous (IV) sedatives, establishing an awake IV access could be very traumatizing and leave a lasting negative impression of the healthcare environment in a child's mind. Hence, enteral medications may be more acceptable and child friendly. This is especially valuable in patients who require repeated surveillance imaging and who demonstrate heightened level of anxiety and fear with each visit. Among sedative agents that could be administered enterally, dexmedetomidine may be superior due to minimal respiratory depression while providing anxiolysis and analgesia. Of note, dexmedetomidine is a highly selective alpha2-adrenoreceptor agonist that exerts its hypnotic action through activation of central pre- and postsynaptic alpha2-receptors in the locus coeruleus, mimicking natural sleep.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 120 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI |
| Actual Study Start Date : | 2025-01-01 |
| Estimated Primary Completion Date : | 2025-08 |
| Estimated Study Completion Date : | 2026-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 4 Months to 6 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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Not yet recruiting
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108