Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
|Official Title:||Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome (RDS)|
- Intubation conditions using a four point scale
- Decrease in time after interruption of sedation until the neonate be awake.
- Decrease in time after interruption of sedation until the neonate be extubated.
- Pain and stress before and after intubation (NIPS and Comfort scores).
- Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||November 2005|
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391105
|Principal Investigator:||Yerkes P Silva, MD, MSc||Faculty of Medicine from Federal University of Minas Gerais|