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NCT00420693 Clinical Trial

Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Newborn Clinical Trial

Official title:
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00420693
Other study ID # 2006/15
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 23, 2006
Last updated January 14, 2009
Start date August 2006

Study information
Verified date January 2009
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sevoflurane

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille CHU Nord Marseille BdR

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lasted realization of the gesture defined by delay between the first draining and the end of the bandage 24 months No
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