Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-01-01 @ 1:37 AM
Study NCT ID:
NCT04608734
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-24', 'studyFirstSubmitDate': '2020-10-24', 'studyFirstSubmitQcDate': '2020-10-24', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of drug administration', 'timeFrame': 'during the sedation procedure', 'description': 'Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.'}, {'measure': 'Sleep score', 'timeFrame': 'after 5 minutes', 'description': 'This will be assessed using modified Houpt scale for behavior rating:\n\n1. Awake, alert.\n2. Drowsy, disoriented.\n3. Intermittently asleep.\n4. Sound asleep.'}, {'measure': 'Crying score', 'timeFrame': 'after 5 minutes', 'description': 'This will be assessed using modified Houpt scale for behavior rating:\n\n1. Hysterical, demands attention.\n2. Continuous, making treatment difficult.\n3. Intermittent, mild, does not interfere with treatment.\n4. No crying present.'}, {'measure': 'Head/oral resistance score', 'timeFrame': 'after 5 minutes', 'description': 'This will be assessed using modified Houpt scale for behavior rating:\n\n1. Turns head, refuses to open mouth.\n2. Mouth closing, must request to open.\n3. Chocking, gagging, spitting.\n4. No head/oral resistance present.'}, {'measure': 'Overall behavior', 'timeFrame': 'immediately after completion of the dental treatment procedures', 'description': 'This will be assessed using modified Houpt scale for behavior rating:\n\n1. Aborted, no treatment performed.\n2. Very poor, treatment interrupted, partial treatment completed.\n3. Fair, difficult, all treatment completed.\n4. Good, some limited crying or movement.\n5. Excellent, no crying or movement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'referencesModule': {'references': [{'pmid': '24357534', 'type': 'BACKGROUND', 'citation': 'Chopra R, Marwaha M. Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20.'}, {'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': '8247896', 'type': 'BACKGROUND', 'citation': 'Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available.'}, {'pmid': '8668567', 'type': 'BACKGROUND', 'citation': 'Kupietzky A, Holan G, Shapira J. Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4.'}, {'pmid': '16435641', 'type': 'BACKGROUND', 'citation': 'Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8.'}, {'pmid': '3857559', 'type': 'BACKGROUND', 'citation': 'Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.', 'detailedDescription': 'Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Negative and definitely negative behavior according Frankl's scale.\n* ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.\n* Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.\n\nExclusion Criteria:\n\n* Children with multiple carious lesions who require treatment under general anesthesia."}, 'identificationModule': {'nctId': 'NCT04608734', 'briefTitle': 'Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients', 'orgStudyIdInfo': {'id': 'Buccal vs intranasal midazolam'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buccal midazolam', 'interventionNames': ['Drug: Buccal midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intranasal midazolam', 'interventionNames': ['Drug: Intranasal midazolam']}], 'interventions': [{'name': 'Buccal midazolam', 'type': 'DRUG', 'description': 'The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.', 'armGroupLabels': ['Buccal midazolam']}, {'name': 'Intranasal midazolam', 'type': 'DRUG', 'description': 'Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.', 'armGroupLabels': ['Intranasal midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yousr N Mowafy, M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Nadia A Wahba, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Tamer M Ghoneim, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Alexandria University, Egypt'}, {'name': 'Ghada M Mahmoud, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, University of Modern Sciences and Arts, Egypt.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}