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Clinical Trials/NCT00420693
NCT00420693
Completed
Phase 2

Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Assistance Publique Hopitaux De Marseille1 site in 1 country60 target enrollmentAugust 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pain Measurement
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
60
Locations
1
Primary Endpoint
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
May 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Lasted realization of the gesture defined by delay between the first draining and the end of the bandage

Time Frame: 24 months

Study Sites (1)

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