Chronic PainPEDIACHRONCT04068350
Epidemiological Study of Post-operative Chronic Pediatric Pain.
An observational study of Chronic Pain and Postoperative Pain, run by University Hospital, Bordeaux.
Trial summary
This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chronic Pain, Postoperative Pain
- What is being tested?
- Pain questionnaire
- How many people
- 582 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2010to 21 Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.
Read the 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.
- Conditions
- Chronic Pain, Postoperative Pain
- Being tested
- Pain questionnaire
- Keywords
- Pediatrics
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain questionnaireOther
Pain questionnaire, 3 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Single arm | The evaluation at 3 months of the postoperative pain will be carried out without the information collected in preoperative and immediate postoperative. Receives: Other: Pain questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start21 Mar 2010
- Primary completion21 Dec 2011
- Study completion21 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BATOZ, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068350
- Sponsor's protocol ID
- CHUBX 2009/18
- Acronym
- PEDIACHRO
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Picat MQ, Pellegrin I, Bitard J, Wittkop L, Proust-Lima C, Liquet B, Moreau JF, Bonnet F, Blanco P, Thiebaut R; ANRS CO3 Aquitaine Cohort. Integrative Analysis of Immunological Data to Explore Chronic Immune T-Cell Activation in Successfully Treated HIV Patients. PLoS One. 2017 Jan 3;12(1):e0169164. doi: 10.1371/journal.pone.0169164. eCollection 2017.
PubMed 28046052
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Post-operative Chronic Pediatric Pain.
- ClinicalTrials.gov ID
- NCT04068350
- Acronym / sponsor ID
- PEDIACHRO / CHUBX 2009/18
- Conditions
- Chronic Pain, Postoperative Pain
- Keywords
- Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Mar 2010 (actual)
- Primary completion
- 21 Dec 2011 (actual)
- Study completion
- 21 Dec 2011 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: Pain questionnaireThe evaluation at 3 months of the postoperative pain will be carried out without the information collected in preoperative and immediate postoperative. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain questionnairePain questionnaire, 3 months after surgery | Other | Single arm |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 28046052Picat MQ, Pellegrin I, Bitard J, Wittkop L, Proust-Lima C, Liquet B, Moreau JF, Bonnet F, Blanco P, Thiebaut R; ANRS CO3 Aquitaine Cohort. Integrative Analysis of Immunological Data to Explore Chronic Immune T-Cell Activation in Successfully Treated HIV Patients. PLoS One. 2017 Jan 3;12(1):e0169164. doi: 10.1371/journal.pone.0169164. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène BATOZ, Dr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Postoperative Pain, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postoperative pain (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.