Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Pain Measurement Newborn

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No