Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT04652661
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2020-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes:\n\nGroup D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of successful sedation', 'timeFrame': 'One hour', 'description': 'Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation.'}], 'secondaryOutcomes': [{'measure': 'The onset time of sedation', 'timeFrame': 'One hour', 'description': 'The onset time of sedation is defined as the time from drug administration to successful sedation.'}, {'measure': 'The occurrence of Adverse effects', 'timeFrame': 'One hour', 'description': 'The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest).'}, {'measure': 'The degree of operator satisfaction', 'timeFrame': 'One hour', 'description': 'MRI operator satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Midazolam', 'MRI', 'Pediatrics']}, 'descriptionModule': {'briefSummary': 'An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.', 'detailedDescription': 'This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.\n\nSixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:\n\nGroup D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.\n\nExclusion Criteria:\n\n1. Patient's guardian refusal.\n2. Body mass index \\>30 kg/m2\n3. Known allergy to dexmedetomidine or midazolam.\n4. Suspected difficult airway.\n5. Upper respiratory tract infection\n6. Anatomical structural deformity of the nasal cavity.\n7. Severe liver or renal impairment.\n8. Severe bradycardia or atrioventricular block above II degree type 2.\n9. Administration of digoxin or beta blockers"}, 'identificationModule': {'nctId': 'NCT04652661', 'briefTitle': 'Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial', 'orgStudyIdInfo': {'id': '32466/11/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine Group', 'description': '30 children will be sedated with 2 μg/kg intranasal dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam Group', 'description': '30 children will be sedated with 0.3 mg/kg intranasal midazolam.', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': '30 children will be sedated with 2 μg/kg intranasal DEX.', 'armGroupLabels': ['Dexmedetomidine Group']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': '30 children will be sedated with 0.3 mg/kg intranasal midazolam.', 'armGroupLabels': ['Midazolam Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'ElGharbiaa', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be provided with a reasonable request from authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Taysser Mahmoud Abdalraheem', 'investigatorAffiliation': 'Tanta University'}}}}