Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-25 @ 4:54 AM
Study NCT ID:
NCT02288650
Status:
UNKNOWN
Last Update Posted:
2014-11-11
First Post:
2013-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 808}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-06', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time between withdrawal of orotracheal tube and POV', 'timeFrame': 'The participant are followed for 3 days.'}]}, 'conditionsModule': {'conditions': ['Post-operative Vomiting Incidence', 'Pediatric Day Case Surgery']}, 'referencesModule': {'references': [{'pmid': '28203729', 'type': 'DERIVED', 'citation': 'Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.'}]}, 'descriptionModule': {'briefSummary': 'At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.\n\nUp to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.\n\nThe main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).\n\nThe secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of less than 4 years old\n* A pediatric day case surgery scheduled\n\nExclusion Criteria:\n\n* Child lower age or 3 month old equal\n* Premature child of conceptional age lower than 60 weeks\n* Anesthetic or surgical constraint dissuading day case surgery or early refeeding\n* Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)\n* treatment interfering with emesis (imidazoles, neuroleptic)\n* Period of exclusion defined by another study'}, 'identificationModule': {'nctId': 'NCT02288650', 'briefTitle': 'Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'orgStudyIdInfo': {'id': '5547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liberal group', 'description': 'Early refeeding', 'interventionNames': ['Other: early refeeding']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Refeeding in the day case ward (usual practice)', 'interventionNames': ['Other: refeeding only in the recovery room (usual practice).']}], 'interventions': [{'name': 'early refeeding', 'type': 'OTHER', 'armGroupLabels': ['Liberal group']}, {'name': 'refeeding only in the recovery room (usual practice).', 'type': 'OTHER', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chloé Chauvin', 'role': 'CONTACT', 'email': 'Chloe.CHAUVIN@chru-strasbourg.fr', 'phone': '3 88 12 70 89', 'phoneExt': '+33'}], 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Chloé CHAUVIN, Doctor', 'role': 'CONTACT', 'email': 'Chloe.CHAUVIN@chru-strasbourg.fr', 'phone': '3 12 70 89', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}