FASS (Facial Action Summary Score) Scale to Differentiate... | NCT02483338

Studies
FASS (Facial Action Summary Score) Scale to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years

NCT02483338

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Jul 9, 2015Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Assessment of pain

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

ID	Type	Description	Link
2011-A00533-38	Registry Identifier	ID-RCB

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jun 25, 2015

First Posted Date

Jun 26, 2015Estimated

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

Jul 8, 2015

Last Update Posted Date

Jul 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children surgery	Other		Behavioral: Assessment of pain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of pain	Behavioral	Assessment of pain using FASS but without using this score to manage pain	Children surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FASS (Facial Action Summary Score)		As soon as the child arrive in recovery room or / and the extubation, before and after the administration of analgesics

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children surgery
Younger than 7 years old
Elective surgery
Patient whose parents will have given their non-opposition

Exclusion Criteria:

Psychological retardation
Chronic pain

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sophie SB BRINGUIER, HP	Contact	0467337960	0033	s-bringuierbranchereau@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Sophie SB BRINGUIER, HP	Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Lapeyronie	Recruiting	Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided