NCT02996058

Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure

Dexmedetomidine Sedation in Pediatric Intensive Care Unit

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine 0.35µg/kg /h	the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
DRUG	Dexmedetomidine 0.5µg/kg /h	the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-01
• Completion: 2018-07-01
• First posted: 2016-12-19
• Last updated: 2018-07-03

Locations

1 site across 1 country: Egypt