Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT06097169
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.', 'description': 'Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.'}, {'measure': 'postoperative anxiety', 'timeFrame': 'anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.', 'description': 'Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidin', 'dental treatment', 'post operative anxiety'], 'conditions': ['Anxiety', 'Postoperative Pain', 'Nausea']}, 'referencesModule': {'references': [{'pmid': '37478025', 'type': 'BACKGROUND', 'citation': 'Zhou D, Yang XD, Wu HY, Xiong GL, Wang LK. Determination of the ED90 of Dexmedetomidine Infusion to Prevent Emergence Agitation in Children Undergoing Dental Rehabilitation With Sevoflurane Anesthesia: A Biased-Coin Up-and-Down Sequential Allocation Trial. Anesth Analg. 2024 Oct 1;139(4):761-769. doi: 10.1213/ANE.0000000000006626. Epub 2024 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\nInclusion Criteria:\n\nPatients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.\n\nExclusion Criteria:\n\ndevelopmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies'}, 'identificationModule': {'nctId': 'NCT06097169', 'briefTitle': 'Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-6155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dex', 'description': 'patients using dexmedetomidine infusion', 'interventionNames': ['Drug: Dexmedetomidine']}, {'label': 'Fen', 'description': 'patients using fentanyl for induction', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Talinat'], 'description': 'In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.', 'armGroupLabels': ['Fen']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.', 'armGroupLabels': ['Dex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34400', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Burak Omur', 'investigatorAffiliation': 'Medipol University'}}}}