NCT04068350

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2011

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 23, 2019

Last Update Submit

August 23, 2019

Conditions

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

  • Chronic postoperative pain

    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

Study Arms (1)

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

Interventions

Pain questionnaire, 3 months after surgery

Single arm

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Hélène BATOZ, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

March 21, 2010

Primary Completion

December 21, 2011

Study Completion

December 21, 2011

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share