NCT00391105

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
Last Updated

October 23, 2006

Status Verified

October 1, 2006

First QC Date

October 19, 2006

Last Update Submit

October 19, 2006

Conditions

Respiratory Distress Syndrome

Keywords

intubationSedationAnalgesiapreterm neonateremifentanilmorphinerespiratory distress syndrome

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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).

Interventions

RemifentanilDRUG

Eligibility Criteria

Age60 Minutes - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16238563BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeAgnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yerkes P Silva, MD, MSc

    Faculty of Medicine from Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 23, 2006

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

October 23, 2006

Record last verified: 2006-10