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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Minas Gerais
• Treatments: Morphine; Remifentanil

Criteria

Inclusion Criteria:

• Gestational age between 28 and 34 wk

• Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.

Exclusion criteria:

• The presence of major congenital malformations

• Birth weigh less than 1000g

• Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)

• Hemodynamic instability before the indication of tracheal intubation

• Refuse of the parents to enroll the neonate in the study protocol