Clinical trial NCT00391105: Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Keywords: intubation
Sedation
Analgesia
preterm neonate
remifentanil
morphine
respiratory distress syndrome
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2006-10-23
Sex: ALL
Minimum age (years): 60
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Intubation conditions using a four point scale
measure: Decrease in time after interruption of sedation until the neonate be awake.
measure: Decrease in time after interruption of sedation until the neonate be extubated.
Secondary outcomes:
measure: Pain and stress before and after intubation (NIPS and Comfort scores).
measure: Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine from Federal University of Minas Gerais
name: Yerkes P Silva, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pereira e Silva Y, Gomez RS, Barbosa RF, Simoes e Silva AC. Remifentanil for sedation and analgesia in a preterm neonate with respiratory distress syndrome. Paediatr Anaesth. 2005 Nov;15(11):993-6. doi: 10.1111/j.1460-9592.2005.01666.x.