Postoperative PainFASSNCT02483338
FASS (Facial Action Summary Score) Scale to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years
A study testing Assessment of pain in people with Postoperative Pain, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Assessment of pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children surgery
- Younger than 7 years old
- Elective surgery
- Patient whose parents will have given their non-opposition
Who cannot join
- Psychological retardation
- Chronic pain
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital Lapeyronie
Montpellier, 34295
Sophie SB BRINGUIER, HP, 0467337960 ext. 0033, s-bringuierbranchereau@chu-montpellier.fr
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- Assessment of pain
- Keywords
- Psychometric validity, Pain scale, Postoperative, Children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of painBehavioural
Assessment of pain using FASS but without using this score to manage pain
| Study group | Role | What they receive |
|---|---|---|
| Children surgery | Other | Not described Receives: Behavioral: Assessment of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
FASS (Facial Action Summary Score)
Measured: As soon as the child arrive in recovery room or / and the extubation, before and after the administration of analgesics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie SB BRINGUIER, HP, Principal investigator, Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483338
- Sponsor's protocol ID
- 8824
- Other IDs
- 2011-A00533-38
- Acronym
- FASS
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the FASS (Facial Action Summary Score) Scale Allow to Differentiate the Pain of Postoperative Anxiety in Children Under 7 Years?
- ClinicalTrials.gov ID
- NCT02483338
- Acronym / sponsor ID
- FASS / 8824
- Conditions
- Postoperative Pain
- Keywords
- Psychometric validity, Pain scale, Postoperative, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to assess postoperative children pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children surgery | Other | Behavioral: Assessment of pain |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children surgery
- Younger than 7 years old
- Elective surgery
- Patient whose parents will have given their non-opposition
Key exclusion criteria (2 listed)
- Psychological retardation
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of painAssessment of pain using FASS but without using this score to manage pain | Behavioural | Children surgery |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie SB BRINGUIER, HP principal investigator
Department of Anesthesia Resuscitation at the Hospital Lapeyronie in Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of pain in people with Postoperative Pain, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie SB BRINGUIER, HP (0467337960 ext. 0033, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.