NCT02483338

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 9, 2015

Status Verified

June 1, 2015

Enrollment Period

4.4 years

First QC Date

June 24, 2015

Last Update Submit

July 8, 2015

Conditions

Postoperative Pain

Keywords

Psychometric validityPain scalePostoperativeChildren

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Children surgery

OTHER
Behavioral: Assessment of pain

Interventions

Assessment of painBEHAVIORAL

Assessment of pain using FASS but without using this score to manage pain

Children surgery

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Psychological retardation
  • Chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Lapeyronie

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sophie SB BRINGUIER, HP

    Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie SB BRINGUIER, HP

CONTACT

0467337960s-bringuierbranchereau@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 26, 2015

Study Start

July 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 9, 2015

Record last verified: 2015-06

Locations

FR(1)