- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00420693
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
January 14, 2009 updated by: Assistance Publique Hopitaux De Marseille
The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care.
Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BdR
-
Marseille, BdR, France, 13008
- Assistance Publique Hopitaux de Marseille CHU Nord
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit
- Patient requiring a mechanical ventilation or CPAP
- Patient requiring a KTEC
- Given consent
Exclusion Criteria:
- Contraindication to sévoflurane
- Patient already sedated with morphin and/or hypnotics
- Patient presenting neurologic troubles
- Patient enrolled in other study*
- Infant without legacy representant
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: Treatment
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: fabrice michel, MD, Assistance Publique Hopitaux de Marseille
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.
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
August 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
November 23, 2006
First Submitted That Met QC Criteria
January 9, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
January 15, 2009
Last Update Submitted That Met QC Criteria
January 14, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/15
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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