- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02483338
FASS (Facial Action Summary Score) Scale to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years (FASS)
July 8, 2015 updated by: University Hospital, Montpellier
Does the FASS (Facial Action Summary Score) Scale Allow to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years?
This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sophie SB BRINGUIER, HP
- Phone Number: 0033 0467337960
- Email: s-bringuierbranchereau@chu-montpellier.fr
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- University Hospital Lapeyronie
-
Contact:
- Sophie SB BRINGUIER, HP
- Phone Number: 0033 0467337960
- Email: s-bringuierbranchereau@chu-montpellier.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 7 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Children surgery
|
Assessment of pain using FASS but without using this score to manage pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
As soon as the child arrive in recovery room or / and the extubation, before and after the administration of analgesics
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sophie SB BRINGUIER, HP, Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
June 24, 2015
First Submitted That Met QC Criteria
June 25, 2015
First Posted (Estimate)
June 26, 2015
Study Record Updates
Last Update Posted (Estimate)
July 9, 2015
Last Update Submitted That Met QC Criteria
July 8, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8824
- 2011-A00533-38 (Registry Identifier: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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