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

Postoperative Pain Clinical Trial

— FASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02483338
• Other study ID #: 8824
• Secondary ID: 2011-A00533-38
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2015
• Last updated: July 8, 2015
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Montpellier
• Contact: Sophie SB BRINGUIER, HP
• Phone: 0467337960
• Email: s-bringuierbranchereau[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: FRANCE: Agence Nationale du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• Assessment of pain
Assessment of pain using FASS but without using this score to manage pain

Locations

Country	Name	City	State
France	University hospital Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No