This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Interest of Using the Sevoflurane in the Prevention of Newborns Pain

This study has been completed.
Information provided by:
Assistance Publique Hopitaux De Marseille Identifier:
First received: November 23, 2006
Last updated: January 14, 2009
Last verified: January 2009
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: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Resource links provided by NLM:

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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Dr Fabrice MICHEL, Assistance Publique Hopitaux De Marseille Identifier: NCT00420693     History of Changes
Other Study ID Numbers: 2006/15
Study First Received: November 23, 2006
Last Updated: January 14, 2009

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 21, 2017