Chronic Pain After Scoliosis and Thoracic Surgery in Children (PEDIACHROII)

June 4, 2018 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Bordeaux, France
    - Centre Hospitalier Universitaire De Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 months after scoliosis and thoracic surgery in children aged 6 to 18 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events after surgery Time Frame: adverse events during peri-operative period (hospital stay, i.e. during the first month 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)
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)	morphine consumption (mg/day)	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)	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)
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)	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)
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	DN4 questionnaire	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	modified FLACC scale for pain	4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified