Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Phase 2

Completed

• Conditions: Pain Measurement; Newborn

• Registration Number: NCT00420693
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-11-23
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Primary Completion: 2008-05
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-14
• Last Update Posted: 2009-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage	24 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille CHU Nord; 🇫🇷 Marseille, BdR, France