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

Phase 4

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT00391105
• Lead Sponsor: Federal University of Minas Gerais

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-04
• Study Completion: 2005-11
• Status Verified: 2006-10
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Last Update Submitted: 2006-10-19
• Study First Posted: 2006-10-23
• Last Update Posted: 2006-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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).