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01
Overview
Phase 4, randomised, double-blind trial in respiratory distress syndrome (RDS) comparing Ketamine with Fentanyl (2 arms). Primary endpoint: Adverse event at 1 hour. Started Feb 2019; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ketamine
Ketamine 1 mg/kg IV + Glycopyrrolate
Fentanyl
Fentanyl 1 mcg/kg IV + Glycopyrrolate
03
Who it enrols
Preterm infants with gestational age at birth >= 26 weeks requiring surfactant treatment via LISA for respiratory insufficiency. Excludes infants with severe RDS requiring intubation, major malformations, or alternative causes of respiratory distress.
04
Endpoints
Primary
Adverse event
Secondary
Duration of the procedure
Number of attempts to get the catether intratracheally
Pain score NIAPAS
The need for additional dosing of study drug or midazolam
Edi-signals
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