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NCT Number: NCT02995525

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.

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Key information

Conditions

Thoracic Surgery Bone Diseases Chronic Pain Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Scoliosis Scoliosis; Adolescence Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier Universitaire de Bordeaux

Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

Acronym: PEDIACHROII

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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