Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome - Full Text View

Sponsor:	Federal University of Minas Gerais
Information provided by:	Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00391105

Purpose

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.

Condition	Intervention	Phase
Respiratory Distress Syndrome	Drug: Remifentanil	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Supportive Care
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)

Resource links provided by NLM:

Drug Information available for: Remifentanil hydrochloride Remifentanil

U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:

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:

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).

Study Start Date:	April 2004
Estimated Study Completion Date:	November 2005

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

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391105

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators

Principal Investigator:

Yerkes P Silva, MD, MSc

Faculty of Medicine from Federal University of Minas Gerais

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00391105 History of Changes
Other Study ID Numbers:	ETIC 287/04
Study First Received:	October 19, 2006
Last Updated:	October 19, 2006
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:

intubation
Sedation
Analgesia
preterm neonate

remifentanil
morphine
respiratory distress syndrome

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Morphine
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012