NCT00420693

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2006

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

January 15, 2009

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

November 23, 2006

Last Update Submit

January 14, 2009

Conditions

Pain MeasurementNewborn

Outcome Measures

Primary Outcomes (1)

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

    24 months

Interventions

sevofluraneDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to sévoflurane
  • Patient already sedated with morphin and/or hypnotics
  • Patient presenting neurologic troubles
  • Patient enrolled in other study\*
  • Infant without legacy representant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille CHU Nord

Marseille, BdR, 13008, France

Location

Related Publications (1)

  • Michel F, Vialet R, Hassid S, Nicaise C, Garbi A, Thomachot L, DI Marco JN, Lagier P, Martin C. Sevoflurane for central catheter placement in neonatal intensive care: a randomized trial. Paediatr Anaesth. 2010 Aug;20(8):712-9. doi: 10.1111/j.1460-9592.2010.03334.x.

    PMID: 20546160DERIVED

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • fabrice michel, MD

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2006

First Posted

January 11, 2007

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Last Updated

January 15, 2009

Record last verified: 2009-01

Locations

FR(1)