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Interest of Using the Sevoflurane in the Prevention of Newborns Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00420693
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : January 15, 2009
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Measurement Newborn Drug: sevoflurane Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Study Start Date : August 2006
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Lasted realization of the gesture defined by delay between the first draining and the end of the bandage [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420693

Assistance Publique Hopitaux de Marseille CHU Nord
Marseille, BdR, France, 13008
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: fabrice michel, MD Assistance Publique Hopitaux De Marseille
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Fabrice MICHEL, Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00420693     History of Changes
Other Study ID Numbers: 2006/15
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs