Sedative Adverse Reaction
Conditions
Keywords
sedation
Brief 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.)
Detailed description
There are several different medications commonly being used to facilitate the administration of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs) require that the patient remain still for the duration of the test. Propofol has become the drug of choice for many sedation services due to its rapid onset of action, rapid recovery time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its main advantage over propofol is that it has minimal respiratory complications when compared to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and induces cooperative sedation in which patients are easily arousable. In pediatric studies, the most frequent adverse effect have been related to its potential to cause hypotension and bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem to have as much impairment of cognitive function and has an opioid sparing effect. Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to propofol, which has limited its use with many sedation services.
Interventions
DRUGPropofol
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
DRUGDexmedetomidine
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
Sponsors
Morehouse School of Medicine
Children's Healthcare of Atlanta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
1. Patient (or Parent/Guardian) is English speaking 2. Patient is undergoing a scheduled, elective non-contrast MRI of the brain 3. Patient is \> 3 months to \<36 months of age
Exclusion criteria
1. Patients undergoing MRI with contrast 2. Patients older than 36 months of age or younger than 3 months of age 3. Patients presenting to Emergency Department (ED) out of screening hours 4. Patients who are not English speaking 5. Patients who have history or record of propofol or dexmedetomidine allergy 6. Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy based products; if patient has a history of a hypersensitivity reaction associated with exposure to eggs, egg products, soybeans, or soy based products, approval must be given by the treating attending physician and documented on the patient's medical record. 7. Patients with unstable cardiac or respiratory status as determined by treating attending physician 8. Patients who are receiving digoxin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural times to achieve optimal sedation | Start of procedure to discharge (up to 8 hours) | Measuring the amount of time it takes for a patient to be discharged starting from induction (start of infusion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation related events | Start of procedure to up to 36 hours post-discharge | Adverse events related to the sedation (i.e., apnea, desaturation, change in heart rate) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-discharge clinical status | Baseline to 24 hours post discharge | Recording any events post-discharge that are possibly sedation-related |
Countries
United States
Contacts
Primary ContactDavid Fagin, MD
Backup ContactLilly H Immergluck, MD
Outcome results
None listed