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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Distress Syndrome focused on measuring intubation, Sedation, Analgesia, preterm neonate, remifentanil, morphine, respiratory distress syndrome

Eligibility Criteria

60 Minutes - 28 Days (Child)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    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).

    Full Information

    First Posted
    October 19, 2006
    Last Updated
    October 19, 2006
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00391105
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Distress Syndrome
    Keywords
    intubation, Sedation, Analgesia, preterm neonate, remifentanil, morphine, respiratory distress syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Primary Outcome Measure Information:
    Title
    Intubation conditions using a four point scale
    Title
    Decrease in time after interruption of sedation until the neonate be awake.
    Title
    Decrease in time after interruption of sedation until the neonate be extubated.
    Secondary Outcome Measure Information:
    Title
    Pain and stress before and after intubation (NIPS and Comfort scores).
    Title
    Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Minutes
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yerkes P Silva, MD, MSc
    Organizational Affiliation
    Faculty of Medicine from Federal University of Minas Gerais
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16238563
    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.
    Results Reference
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    Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome

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