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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391105
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : October 23, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Remifentanil Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : April 2004
Study Completion Date : November 2005

Primary Outcome Measures :
  1. Intubation conditions using a four point scale
  2. Decrease in time after interruption of sedation until the neonate be awake.
  3. Decrease in time after interruption of sedation until the neonate be extubated.

Secondary Outcome Measures :
  1. Pain and stress before and after intubation (NIPS and Comfort scores).
  2. Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391105

Sponsors and Collaborators
Federal University of Minas Gerais
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Principal Investigator: Yerkes P Silva, MD, MSc Faculty of Medicine from Federal University of Minas Gerais

Layout table for additonal information Identifier: NCT00391105     History of Changes
Other Study ID Numbers: ETIC 287/04
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006
Keywords provided by Federal University of Minas Gerais:
preterm neonate
respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents