Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-03 @ 2:21 PM
Study NCT ID:
NCT03357718
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Dexmedetomidine vs Midazoam For Premedication
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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Retrospective clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ramsey Sedation Scale', 'timeFrame': '45 minutes after premedication', 'description': 'Sedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score \'1\' was considered as unsatisfactory and "≥ 2" was considered as satisfactory sedation.'}], 'secondaryOutcomes': [{'measure': 'Parental Separation Anxiety Scale', 'timeFrame': 'Preoperative', 'description': "Behavior of the child on seperation from the parents was assessed according to a four-point scale, i.e., the parental seperation anxiety scale (PSAS): 1= Easy seperation, 2=Whimpers but easily reassured, 3=Cries and cannot be easily reassured, but not clinging to parents, 4=Cries and clinging to parents. A PSAS score of 1 and 2 were considered as 'successful parental seperation'."}, {'measure': 'Mask Acceptance Score', 'timeFrame': 'Before induction', 'description': "Mask acceptance was evaluated using a four-point scale, i.e., mask acceptance scale (MAS):\n\n1=Excellent (unafraid, cooperative, and accepts mask easily), 2=Good (slight fear of mask , easily reassured), 3=Fair (moderate fear of mask, not calmed with reassurance), 4=Poor (terrified, crying, or combative). The score of 1 and 2 considered as 'satisfactory' mask acceptance."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premedication'], 'conditions': ['Premedication']}, 'referencesModule': {'references': [{'pmid': '28298782', 'type': 'BACKGROUND', 'citation': 'Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.', 'detailedDescription': "The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.\n\nThe patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.\n\nExclusion Criteria:\n\n* The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.'}, 'identificationModule': {'nctId': 'NCT03357718', 'briefTitle': 'Oral Dexmedetomidine vs Midazoam For Premedication', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment', 'orgStudyIdInfo': {'id': '2017/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': '2 µg/kg Precedex', 'interventionNames': ['Drug: Precedex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': '0.5 mg/kg dormicum', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Precedex', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': '2 µg/kg oral', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': '0.5 mg/kg', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sultan KELES, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adnan Menderes University Faculty of Dentistry Aydın'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.Dr.', 'investigatorFullName': 'Sultan KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}