Thoracic SurgeryPEDIACHROIINCT02995525
Chronic Pain After Scoliosis and Thoracic Surgery in Children
An observational study of Thoracic Surgery and Scoliosis; Adolescence, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Thoracic Surgery, Scoliosis; Adolescence, Pediatric ALL
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Jun 2018
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital
Who may be able to join
- children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital.
Who cannot join
- patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.
The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.
The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.
- Conditions
- Thoracic Surgery, Scoliosis; Adolescence, Pediatric ALL, Chronic Pain
- Medical subject headings
- Scoliosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
pain at 4 months after surgery
visual analogue scale for pain (0_100)
Measured: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years
Secondary outcomes (6)
adverse events after surgery
infections, neurologic defect, new surgery, blood hematoma
Measured: adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)
morphine consumption during the perioperative period
morphine consumption (mg/day)
Measured: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
pain during the perioperative period
visual analogue scale for pain (0-100)
Measured: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
pain during the perioperative period in disabled children aged 6 to 18 years
FLACC scale level (0-100)
Measured: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery
DN4 questionnaire
Measured: 2'4-48 h hours period after surgery, 4 months after surgery
pain at 4 months after surgery
modified FLACC scale for pain
Measured: 4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995525
- Sponsor's protocol ID
- CHUBXSAR32016-02
- Acronym
- PEDIACHROII
- Status last verified
- Dec 2016
- First submitted
- 10 Nov 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
PubMed 28077537
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children
- ClinicalTrials.gov ID
- NCT02995525
- Acronym / sponsor ID
- PEDIACHROII / CHUBXSAR32016-02
- Conditions
- Thoracic Surgery, Scoliosis; Adolescence, Pediatric ALL, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Dec 2016 (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.
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.
The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.
The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital
Key inclusion criteria (1 listed)
- children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital.
Key exclusion criteria (1 listed)
- patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain at 4 months after surgery
Time frame: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years
visual analogue scale for pain (0_100)
6 secondary outcomes
adverse events after surgery
Time frame: adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)
morphine consumption during the perioperative period
Time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
pain during the perioperative period
Time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
pain during the perioperative period in disabled children aged 6 to 18 years
Time frame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery
Time frame: 2'4-48 h hours period after surgery, 4 months after surgery
pain at 4 months after surgery
Time frame: 4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Results publication: PubMed 28077537Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Scoliosis; Adolescence, run by University Hospital, Bordeaux 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain at 4 months after surgery (time frame: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995525, which also lists 1 linked publication.
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 6 Jun 2018.