Clinical trial NCT02995525: Chronic Pain After Scoliosis and Thoracic Surgery in Children
Official title: Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Scoliosis; Adolescence
Pediatric ALL
Chronic Pain
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital.

Exclusion Criteria:

* patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.

Primary outcomes:
measure: pain at 4 months after surgery
timeFrame: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years
Secondary outcomes:
measure: adverse events after surgery
timeFrame: adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)
measure: morphine consumption during the perioperative period
timeFrame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
measure: pain during the perioperative period
timeFrame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
measure: pain during the perioperative period in disabled children aged 6 to 18 years
timeFrame: the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
measure: prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery
timeFrame: 2'4-48 h hours period after surgery, 4 months after surgery
measure: pain at 4 months after surgery
timeFrame: 4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre hospitalier Universitaire de Bordeaux
Study officials:
References:
citation: 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.