Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-04 @ 9:37 PM
Study NCT ID:
NCT03852602
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2019-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative dental pain', 'timeFrame': 'An average of 24 hours postoperatively', 'description': 'Wong-Baker faces Scale is validated for children aged 3 to 7 years, includes six cartoon faces corresponding to scores 0-5 (0=no hurt, 1= hurts a little bit, 2= hurts a little more, 3=hurts even more, 4= hurts a whole lot, 5=hurts worst).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '28618198', 'type': 'BACKGROUND', 'citation': 'Kharouba J, Hawash N, Peretz B, Blumer S, Srour Y, Nassar M, Sabbah M, Safadi A, Khorev A, Somri M. Effect of intravenous paracetamol as pre-emptive compared to preventive analgesia in a pediatric dental setting: a prospective randomized study. Int J Paediatr Dent. 2018 Jan;28(1):83-91. doi: 10.1111/ipd.12311. Epub 2017 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.', 'detailedDescription': "The investigator's study included patients who were admitted to Inonu University and Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry in 2019 and decided to perform dental treatment under general anesthesia. Patients 1 to 7 years of age with dental treatment between February 28 and June 1, 2019 will be included.\n\nPatients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. Paracetamol 15 mg / kg IV will be given in 50 ml of saline.\n\nThe demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children who will be treated under general anesthesia because of lack of chairside cooperation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be treated under general anesthesia\n* No systemic disease\n* To have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy\n\nExclusion Criteria:\n\n* Patients with mental or physical disabilities of any disease\n* Patients who have not undergone painful dental intervention under general anesthesia'}, 'identificationModule': {'nctId': 'NCT03852602', 'briefTitle': 'Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia in Children', 'orgStudyIdInfo': {'id': '2019-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Control', 'description': 'Analgesic application15 minutes before the end of the treatment will constitute the control group.', 'interventionNames': ['Drug: Control']}, {'label': 'Group preemptive', 'description': 'Patients who underwent analgesic 15 minutes after the induction of general anesthesia .', 'interventionNames': ['Drug: Preemptive Analgesics']}], 'interventions': [{'name': 'Preemptive Analgesics', 'type': 'DRUG', 'description': 'Analgesic application15 minutes before the treatment', 'armGroupLabels': ['Group preemptive']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Preventive analgesic'], 'description': 'Analgesic application15 minutes before the end of the treatment', 'armGroupLabels': ['Group Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Sultan KELES', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Sultan Keles, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Aydin Adnan Menderes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Study will be conducted and then will be published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inonu University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.Dr.', 'investigatorFullName': 'Sultan KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}