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There is a significant lack of adequately powered randomized clinical trial (RCT) data to determine the comparative safety and effectiveness of sedative treatments in pediatric patients. In many centres the standard of care for sedation in pediatric critical care unit (PCCU) patients includes the use of benzodiazepines despite the known negative effects of increased patient agitation and delirium, which can contribute to longer PCCU and hospital length of stay (LOS). The use of an alternative sedative, dexmedetomidine may reduce negative effects in this population. As such, the investigators plan to conduct a well designed comparative RCT to determine the most effective and safest sedative in this vulnerable population utilizing clinical assessments of sedation levels and delirium instance, electroencephalography (EEG) analysis and patient important outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator |
| |
| Midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precedex | Drug | Precedex, dexmedetomidine hydrochloride, IV, 4mcg/mL, infusion duration determined by the clinical care team |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Sedation Range | The percentage of time spent within target sedation range, defined as COMFORT Behaviour Scale score of 11-22, which will be assessed at minimum every 4 hours. | Up to 14 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Prevalence of delirium using the Cornell Assessment of Pediatric Delirium (CAPD) tool | Up to 14 days post-randomization |
| Delirium | Duration of delirium using the Cornell Assessment of Pediatric Delirium (CAPD) tool |
| Measure | Description | Time Frame |
|---|---|---|
| Economic Analysis | The investigators will perform an economic evaluation during this pilot trial. This will be cost estimate analysis based on approximate costs incurred daily in the PCCU. Costs will be determined at discharge from estimated cost per day of admission to the PCCU. | Up to 90 days post-randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maysaa Assaf, BSc | Contact | 519-685-8500 | 77548 | maysaa.assaf@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Douglas D Fraser, MD., PhD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital - London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Midazolam, IV, 5mg/mL (for patients more than 10kg), 1mg/mL (for patients 2-10kg), infusion duration determined by the clinical care team |
|
| Up to 14 days post-randomization |
| Delirium | Prevalence of delirium using raw and quantitative EEG | Up to 14 days post-randomization |
| Delirium | Duration of delirium using raw and quantitative EEG | Up to 14 days post-randomization |
| Duration of mechanical ventilation | Mechanical ventilation-free days through day 28 will be calculated as 28 minus the duration of mechanical ventilation. Participants who die, are still receiving mechanical ventilation, or are transferred from the PCCU still receiving mechanical ventilation by day 28 will be censored at 28 days and assigned zero mechanical ventilation-free days | Up to 28 days post-randomization |
| PCCU Length of Stay | Length of stay will be calculated from the time of PCCU admission to the time of PCCU discharge. | Up to 90 days post-randomization |
| Hospital Length of Stay | Hospital Length of Stay will be calculated from the time of PCCU admission to the time of physical hospital discharge. | Up to 90 days post-randomization |
| Adverse event (AE) occurrence | Documentation of treatment related adverse events including blood pressure/heart rate changes requiring decreasing or discontinuation of study drug or intervention, delirium requiring medical treatment, any unplanned extubation or line removals, aspirations, ulcerations, etc.determined to result from inadequate sedation | Randomization to 90 days post-randomization |
| Quantification of sleep stages and sleep quality assessment | Visual and automated scoring of sleep stages from EEG recordings Stage 1 sleep: scored when more than 15 seconds of the epoch is made up of theta activity (4to7 Hz) Stage 2 sleep: predominant theta activity (4 to 7 Hz) and occasional quick bursts of faster activity Stage 3/4 sleep: marked by high-amplitude slow waves Rapid eye movement (REM) sleep: characterized by low-amplitude, mixed-frequency theta waves, intermixed with some alpha waves (usually 1 to 2 Hz slower than wake). | Up to 14 days post-randomization |
| Pharmacokinetics - Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) | Up to 14 days post-randomization |
| Pharmacokinetics - Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration-time curve (AUC) | Up to 14 days post-randomization |
| Use of open label boluses for sedation - number | Number of boluses (opioid and benzodiazepine) administered during the treatment period | Up to 14 days post-randomization |
| Use of open label boluses for sedation - total dose | Total dose of boluses (opioid and benzodiazepine) administered during the treatment period | Up to 14 days post-randomization |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |