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Interest of Using the Sevoflurane in the Prevention of Newborns Pain

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00420693
First received: November 23, 2006
Last updated: January 14, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Pain Measurement
Newborn
 Drug: sevoflurane
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Resource links provided by NLM:

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

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Lasted realization of the gesture defined by delay between the first draining and the end of the bandage [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420693

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

No publications provided by Assistance Publique Hopitaux De Marseille

Additional 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
Study First Received: November 23, 2006
Last Updated: January 14, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013