Goal-Directed Sedation in Mechanically Ventilated Infants and Children (mini-MENDS)
Delirium, Critical Illness, Sedation Complication
About this trial
This is an interventional prevention trial for Delirium focused on measuring pediatrics, critical care, agitation, sedation, delirium
Eligibility Criteria
Inclusion Criteria:
- Patients will be eligible for enrollment if they are 1) aged ≥ 6 months and < 11 years, 2) admitted to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) on mechanical ventilation (MV) requiring sedation. Pre-pubescent children (<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction.
Exclusion Criteria: Patients will be excluded (i.e., not approached for consent) if any one is present:
- Receiving continuous sedation for > 48 hours prior to screening
- Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV.
- Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness.
- Clinically significant 2nd or 3rd degree heart block or bradycardia < 60 beats per minute.
- Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion).
- Inability to co-enroll with another study.
- Expected death or care plan for withdrawal of support measures within 24 hours of enrollment.
- Bilateral vision loss.
- Inability to understand English or deafness that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation services are actively available in that particular language.
- Documented allergy to either dexmedetomidine or midazolam.
- Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening.
Inability to start the informed consent process within the 48 hours from the time that all inclusion criteria were met (possible reasons):
- Attending physician refusal
- 48-hour period of eligibility was exceeded before the patient was screened
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) refusal
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) unavailable
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) is non-English speaking and available research staff is not proficient and/or translation services are not available in that particular language.
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Dexmedetomidine
Midazolam
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 4 mcg/mL or 8 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr.
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 0.5 mg/mL or 1 mg/mL midazolam. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr.