Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05003102
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05003102
Study Brief:
Protocol Section:
NCT05003102