Clinical trial NCT02996058: Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure
Official title: Dexmedetomidine Sedation in Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sedation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

Detailed description: Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.

Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.

The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.

The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.

Eligibility criteria: Inclusion Criteria:

* Infants (1-12 months).
* Respiratory failure/
* Requiring PICU admission and mechanical ventilation up to 72h.

Exclusion Criteria:

* Significant renal, hepatic, endocrine or metabolic disease.
* 2nd or 3rd degree heart block.
* hypotension or bradycardia (defined as any value outside the normal range from the patient's age).

Primary outcomes:
measure: University of Michigan sedation scale
timeFrame: 72H
Secondary outcomes:
measure: The blood pressure
timeFrame: 72h
measure: The heart rate
timeFrame: 72h
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Pediatric hospital
state: Assiut Governorate
Study officials:
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: