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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of pain
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Psychometric validity, Pain scale, Postoperative, Children

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital LapeyronieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children surgery

Arm Description

Outcomes

Primary Outcome Measures

FASS (Facial Action Summary Score)

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
July 8, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02483338
Brief Title
FASS (Facial Action Summary Score) Scale to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years
Acronym
FASS
Official Title
Does the FASS (Facial Action Summary Score) Scale Allow to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Psychometric validity, Pain scale, Postoperative, Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children surgery
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Assessment of pain
Intervention Description
Assessment of pain using FASS but without using this score to manage pain
Primary Outcome Measure Information:
Title
FASS (Facial Action Summary Score)
Time Frame
As soon as the child arrive in recovery room or / and the extubation, before and after the administration of analgesics

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie SB BRINGUIER, HP
Phone
0467337960
Ext
0033
Email
s-bringuierbranchereau@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie SB BRINGUIER, HP
Organizational Affiliation
Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie SB BRINGUIER, HP
Phone
0467337960
Ext
0033
Email
s-bringuierbranchereau@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

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

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