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

Sedation Clinical Trial

— DEXinPICU  

Official title:

Dexmedetomidine Sedation in Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996058
• Other study ID #: IRB00008718/00436
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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).

Related Conditions & MeSH terms

• Sedation

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Pediatric hospital	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	University of Michigan sedation scale	The university of Michigan sedation scale (UMSS) will be assessed every hour	72H
Secondary	The blood pressure	The invasive arterial blood pressure will be recorded every hour	72h
Secondary	The heart rate	The heart rate will be recorded every hour.	72h