Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-26 @ 10:59 PM
Study NCT ID:
NCT04068350
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study of Post-operative Chronic Pediatric Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 582}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2011-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic postoperative pain', 'timeFrame': '3 months after surgery', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatrics'], 'conditions': ['Chronic Pain', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.', 'detailedDescription': '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.\n\nIn 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.\n\nThis study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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:\n\n* Thoracotomies and thoracoscopies\n* Cholécysctectomie\n* Laparotomy and appendectomy\n* Inguinal surgery (inguinal hernia and testicular ectopia)\n* Orthopedic surgery\n* Urologic surgery (hypospadias, circumcision and upper urinary tract surgery)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll 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.\n\nAll patients who consented to participate in the research.\n\nExclusion Criteria:\n\n* All children operated on outpatient surgery.\n* Children and parents with difficulties in understanding the questionnaires.\n* Refusal of the child or one of the parents.\n* Change of home planned during the post-operative follow-up period (3 months).'}, 'identificationModule': {'nctId': 'NCT04068350', 'acronym': 'PEDIACHRO', 'briefTitle': 'Epidemiological Study of Post-operative Chronic Pediatric Pain.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Epidemiological Study of Post-operative Chronic Pediatric Pain.', 'orgStudyIdInfo': {'id': 'CHUBX 2009/18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single arm', 'description': 'The evaluation at 3 months of the postoperative pain will be carried out without the information collected in preoperative and immediate postoperative.', 'interventionNames': ['Other: Pain questionnaire']}], 'interventions': [{'name': 'Pain questionnaire', 'type': 'OTHER', 'description': 'Pain questionnaire, 3 months after surgery', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hélène BATOZ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}