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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00391105
First received: October 19, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 23, 2014