Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Douglas Fraser
• Treatments: Dexmedetomidine; Midazolam

Criteria

Inclusion Criteria:

1. Age is 1 month to 18 years inclusive

2. The patient is intubated and is expected to remain intubated for at least the next 48 hours

3. The patient has not been receiving mechanical ventilation for more than 72 hours

4. The patient must already be receiving an opioid infusion per PCCU sedation/analgesia guidelines and be in need of additional sedation.

Exclusion Criteria:

1. Admission is a consequence of trauma or burn

2. Admission is a consequence of suspected or proven drug overdose

3. Patient is receiving dialysis

4. Known pregnancy or lactation

5. Neuromuscular blockade other than for intubation

6. General anesthesia in the 24 hours prior to study initiation

7. Pre-existing Central Nervous System (CNS) dysfunction or an acquired condition resulting in ongoing dysfunction

8. Acute hepatitis or severe liver disease

9. Known history of sensitivity to midazolam and/or dexmedetomidine or their constituents

10. Systolic blood pressure (SBP) below 5th percentile for two consecutive measurements

11. Heart rate (HR) below 5th percentile for two consecutive measurements

12. The patient is receiving vasoactive medication for the purpose of maintaining cardiovascular goals

13. Death is deemed to be imminent or inevitable during the admission and either the intensivist or substitute decision maker is not committed to full active resuscitation

14. Previous enrollment into the study