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
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
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
NCT ID
NCT00391105
First Posted
October 19, 2006
Last Updated
October 19, 2006
Sponsor
Federal University of Minas Gerais
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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