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

November 23, 2006
January 14, 2009
August 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00420693 on ClinicalTrials.gov Archive Site
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Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain Measurement
  • Newborn
Drug: sevoflurane
Not Provided
Michel F, Vialet R, Hassid S, Nicaise C, Garbi A, Thomachot L, DI Marco JN, Lagier P, Martin C. Sevoflurane for central catheter placement in neonatal intensive care: a randomized trial. Paediatr Anaesth. 2010 Aug;20(8):712-9. doi: 10.1111/j.1460-9592.2010.03334.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
May 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00420693
2006/15
Not Provided
Dr Fabrice MICHEL, Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: fabrice michel, MD Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP