Epidemiological Study of Post-operative Chronic Pediatric Pain. (PEDIACHRO)

August 23, 2019 updated by: University Hospital, Bordeaux
This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of the operated adults. The factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy.

In pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. On the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults.

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Study Type

Observational

Enrollment (Actual)

582

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital. The main interventions concerned by this protocol are:

  • Thoracotomies and thoracoscopies
  • Cholécysctectomie
  • Laparotomy and appendectomy
  • Inguinal surgery (inguinal hernia and testicular ectopia)
  • Orthopedic surgery
  • Urologic surgery (hypospadias, circumcision and upper urinary tract surgery)

Description

Inclusion Criteria:

All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital.

All patients who consented to participate in the research.

Exclusion Criteria:

  • All children operated on outpatient surgery.
  • Children and parents with difficulties in understanding the questionnaires.
  • Refusal of the child or one of the parents.
  • Change of home planned during the post-operative follow-up period (3 months).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single arm
The evaluation at 3 months of the postoperative pain will be carried out without the information collected in preoperative and immediate postoperative.
Other: Pain questionnaire
Pain questionnaire, 3 months after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic postoperative pain
Time Frame: 3 months after surgery
Visual analogic scale from 0 to 100: (between 0 and 30: low pain, between 30 and 60: moderate pain, between 60 and 100: severe pain)
3 months after surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Hélène BATOZ, Dr, University Hospital, Bordeaux

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)

March 21, 2010

Primary Completion (ACTUAL)

December 21, 2011

Study Completion (ACTUAL)

December 21, 2011

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2009/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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