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

October 19, 2006 updated by: Federal University of Minas Gerais

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 23, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2006

Last Update Submitted That Met QC Criteria

October 19, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETIC 287/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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