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Continuous Infusion of Fentanyl in Preterm on MV

NCT00571636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2011-10-12

No results posted yet for this study

Summary

The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA \<= 32 weeks in MV:

* Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;
* Group B) continuous infusion of placebo + open label boluses of Fentanyl.

Conditions

  • Pain
  • Infant, Premature, Diseases
  • Respiration; Insufficient or Poor, Newborn

Interventions

DRUG

Fentanyl

The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols. Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is \> 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage.

DRUG

5% glucose solution

ev continuous infusion

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Gina Ancora, Doctor · St'Orsola-Malpighi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-04-30
Completion
2010-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571636 on ClinicalTrials.gov