Cord Tethering or Malformation, Cord Tumor Compression or Instability, Developmental Delay and Behavioral Changes, Encephalopathy
Conditions
Keywords
Sedation, MRI, pediatric, propofol, brain, spine, quality of MRI, Continuous propofol dosing, continuous propofol administration, Intermittent propofol dosing, intermittent propofol administration, Sedative agent, propofol continuous infusions, Recovery time, Complications of sedation, bolus dosing
Brief summary
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Detailed description
A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.
Interventions
PROCEDUREIntermittent Propofol Sedation
Intermittent versus continuous dosage
PROCEDUREContinuous Propofol Sedation
intermittent vs continuous dosage
Sponsors
Helen DeVos Children's Hospital
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 1 month to 18 years * Receiving a brain or spine MRI with propofol sedation * Deemed safe to undergo sedation with propofol based on a pre-sedation examination * Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications
Exclusion criteria
* Patient below or above set age limits. * Patient requires MRI studies on other body areas. * Patient requires pre-medication with a sedative or tranquilizer * Patient requires additional medications during sedation to complete the procedure. * Propofol is being used as a rescue sedative to complete the procedure. * Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative. * Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic. * Insulin dependent diabetes * Thyroid disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing | study completion |
Countries
United States
Outcome results
None listed