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Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

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)

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00391105
Study type Interventional
Source Federal University of Minas Gerais
Contact
Status Completed
Phase Phase 4
Start date April 2004
Completion date November 2005
View Details
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