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

Federal University of Minas Gerais

Status and phase

Completed

Phase 4

Conditions

Respiratory Distress Syndrome

Treatments

Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT00391105

ETIC 287/04

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

60 minutes to 28 days old

Volunteers

No Healthy Volunteers

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