Interest of Using the Sevoflurane in the Prevention of Ne... | NCT00420693

Studies
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

NCT00420693

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Jan 15, 2009Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Pain Measurement
Newborn

Interventions

sevoflurane

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

May 2008Actual

Completion Date

Not provided

First Submitted Date

Nov 23, 2006

First Submission Date that Met QC Criteria

Jan 9, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2009

Last Update Posted Date

Jan 15, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
sevoflurane	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage		24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
fabrice michel, MD	Assistance Publique Hopitaux De Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille CHU Nord		Marseille	BdR	13008	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20546160	Derived	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.

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated