Dexmedetomidine Cycling and Sleep in the Pediatric ICU

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of mechanically ventilated pediatric intensive care unit (ICU) teenage patients and the effects of the medication dexmedetomidine on sleep, delirium, and sedation level. The Investigators will assess sleep with an 8 lead polysomnogram study and increase the medication at night for one night to see if the sleep architecture changes. The Investigators will assess their sleep with our unit's sedation protocol for an additional night.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Dexmedetomidine; Fentanyl

Criteria

Inclusion Criteria:

• Patients who are intubated and ages 12 years and 0 days old to 17 years and 364 days old who are admitted to the Pediatric intensive care unit and who are on the sedation protocol with use of at least an intravenous dexmedetomidine infusion

• Patients will be selected from those admitted from the emergency room for traumas and critical illness as well as those admitted for post-operative care

• Prematurity, history of permanent neurological damage, autism spectrum disorder, presence of genetic conditions will not preclude enrollment

Exclusion Criteria:

• Patients taking clonidine daily prior to admission

• Those with allergy to dexmedetomidine

• Those on non-intravenous forms of dexmedetomidine

• Those on a ketamine, propofol, pentobarbital, or paralytic infusions

• Those with a diagnosis of refractory status epilepticus

• Patients with vision loss

• Those admitted for care following a cardiac arrest

• Those with a history of hemodynamic instability with dexmedetomidine infusion and lack of a permanent pacemaker or implantable cardioverter-defibrillator

• Those with International Normalized Ratio (INR) >3.2 (due to concerns for reduction in clearance by 50% in pediatric patients at that level of coagulopathy)

• Those on antiarrhythmics (due to association with cardiac arrest with dexmedetomidine and amiodarone and concerns with administration while on digoxin)

• Those with a Glascow Coma Scale (GCS) of 3T or less at presentation

• Those on sedation for end of life comfort