Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Newborn; Pain Measurement

Treatments: Drug: sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT00420693

2006/15

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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