NCT00420693
Completed
Phase 2
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Drugssevoflurane
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.
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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