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Ketamine Clinical Trials

Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)

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Id: NCT03705468

Organisation Name: University Hospital, Montpellier

Overal Status: Completed

Start Date: September 19, 2018

Last Update: April 18, 2019

Lead Sponsor: University Hospital, Montpellier

Brief Summary: Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). The strategy to manage RDS relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. During recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (CPAP) has emerged as a new approach for treating neonates with respiratory failure. The main objectives of Less Invasive Surfactant Administration (LISA) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. The LISA premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. This reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. This study aims to optimize sedation during LISA procedure by evaluating pain score with Ketamine or Protofol sedation, in Neonatal intensive care unit (NICU) patients with RDS.

• Premature Neonate