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
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.
- 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