Interest of Using the Sevoflurane in the Prevention of Newborns Pain

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.

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Key information

Conditions

Pain Measurement Newborn

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assistance Publique Hopitaux de Marseille CHU Nord

Marseille, BdR, 13008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Primary outcomes

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

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
First posted: Jan 11, 2007
Registry last updated: Jan 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed