Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-31 @ 1:08 AM
Study NCT ID:
NCT04237532
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2020-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of drug administration', 'timeFrame': 'during the sedation procedure', 'description': 'Assessed by a 4 point Likert scale as follows: 1 (Good) the child accepted the drug without any refusal. 2 (fair) the child accepted the drug with some verbal resistance. 3 (poor) the child accepted the drug with some physical resistance. 4 (refused) the child refused but drug administration was possible after persuation.'}, {'measure': 'Level of Sedation', 'timeFrame': 'during the sedation procedure', 'description': 'Time taken by both routes to reach the desired level of sedation using Wilton et al sedation scale and it is scored as follows: 1. Agitated: Clinging parent and/or crying. 2.Alert: Awake, but not clinging to parent may whimper but not crying. 3.Calm: Sitting or lying comfortably with eyes spontaneously open. 4.Drowsy: Sitting or lying comfortably with eyes spontaneously closing but responds to minor stimulation. 5. Asleep: Eyes closed, rousable, does not respond to minor stimulation.'}, {'measure': 'Anxiety level', 'timeFrame': 'during the sedation procedure', 'description': "Anxiety level during local anesthesia administration will be evaluated using Venham's clinical anxiety scale. 0: Relaxed child, 1: Uneasy, concerned, 2:Child appears scared, 3:Shows reluctance to enter situation, difficulty in correctly assessing situational threat, 4:Anxiety interferes with ability to assess situation."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-anxiety Agents', 'Moderate Sedation']}, 'referencesModule': {'references': [{'pmid': '11309871', 'type': 'BACKGROUND', 'citation': 'al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.'}, {'pmid': '3195771', 'type': 'BACKGROUND', 'citation': 'Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.'}, {'pmid': '6938934', 'type': 'BACKGROUND', 'citation': "Venham LL, Gaulin-Kremer E, Munster E, Bengston-Audia D, Cohan J. Interval rating scales for children's dental anxiety and uncooperative behavior. Pediatr Dent. 1980 Sep;2(3):195-202. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment', 'detailedDescription': 'Each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. At the first visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. At least one week interval between the two visits will be secured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Frankl behavior rating score 2.\n* ASA I physical status.\n* Dental intervention under local anesthesia not requiring more than 30 minutes.\n* No previous dental experience.\n* Parent/guardian written consent.\n\nExclusion Criteria:\n\n* Dental treatment indicated requiring general anesthesia.\n* Mouth breathers.\n* Patients with acute upper respiratory illness.\n* Medically compromised patients.\n* Cognitively impaired patients.'}, 'identificationModule': {'nctId': 'NCT04237532', 'briefTitle': 'Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Effectiveness of Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'Sublingual vs intranasal DEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Dexmedetomidine', 'interventionNames': ['Drug: Intranasal Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Sublingual Dexmedetomidine', 'interventionNames': ['Drug: Sublingual Dexmedetomidine']}], 'interventions': [{'name': 'Intranasal Dexmedetomidine', 'type': 'DRUG', 'description': 'The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.', 'armGroupLabels': ['Intranasal Dexmedetomidine']}, {'name': 'Sublingual Dexmedetomidine', 'type': 'DRUG', 'description': 'The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.', 'armGroupLabels': ['Sublingual Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'May Shaat, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Niveen Bakry, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Dalia M Talaat, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Ahmed M El-Shafei, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Instructor of Dental Public Health; Statistician', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}