Chronic Pain After Scoliosis and Thoracic Surgery in Children

Chronic Pain Clinical Trial

— PEDIACHROII  

Official title:

Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995525
• Other study ID #: CHUBXSAR32016-02
• Status: Completed
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: December 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pediatric ALL
• Scoliosis
• Scoliosis; Adolescence
• Thoracic Surgery

Locations

Country	Name	City	State
France	Centre hospitalier Universitaire de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (1)

Batoz H, Semjen F, Bordes-Demolis M, Bénard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain at 4 months after surgery	visual analogue scale for pain (0_100)	4 months after scoliosis and thoracic surgery in children aged 6 to 18 years
Secondary	adverse events after surgery	infections, neurologic defect, new surgery, blood hematoma	adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)
Secondary	morphine consumption during the perioperative period	morphine consumption (mg/day)	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
Secondary	pain during the perioperative period	visual analogue scale for pain (0-100)	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
Secondary	pain during the perioperative period in disabled children aged 6 to 18 years	FLACC scale level (0-100)	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)
Secondary	prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery	DN4 questionnaire	2'4-48 h hours period after surgery, 4 months after surgery
Secondary	pain at 4 months after surgery	modified FLACC scale for pain	4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years