Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT05883150
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-05-20', 'studyFirstSubmitQcDate': '2023-05-20', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavior rating', 'timeFrame': 'throughout the sedation session', 'description': 'This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior'}], 'secondaryOutcomes': [{'measure': 'Onset of sedation', 'timeFrame': 'during the sedation procedure (after drug administration until reaching satisfactory sedation)', 'description': 'The time taken for sedative drugs to start their action will be recorded using a stopwatch'}, {'measure': 'Level of sedation', 'timeFrame': 'during the sedation procedure (after drug administration until reaching satisfactory sedation)', 'description': 'The level of sedation Agitated will be scored using a Five point sedation scale\n\n* Agitated - Clinging to parent/crying\n* Alert - Awake, not clinging to parent/no cry\n* Calm - Sitting or lying comfortably with eyes spontaneously open eyes spontaneously closed but responds\n* Drowsy: Comfortable with minor stimuli\n* Asleep: Eyes closed, arousable, does not respond to minor stimuli.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Sedation']}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Frankl scale score 2.\n* ASA I or II physical status.\n* Dental intervention under local anesthesia not requiring more than 30 minutes.\n* No previous dental experience.\n* Parent/guardian's written consent.\n\nExclusion Criteria:\n\n* Dental treatment indicated under general anesthesia.\n* Presence of facial or nasal deformities.\n* History of neurological or cognitive alterations.\n* Mouth breathers"}, 'identificationModule': {'nctId': 'NCT05883150', 'briefTitle': 'Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized Midazolam', 'interventionNames': ['Drug: Nebulized Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intranasal Midazolam', 'interventionNames': ['Drug: Intranasal Midazolam']}], 'interventions': [{'name': 'Nebulized Midazolam', 'type': 'DRUG', 'description': 'All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child The sedative drug, the dosage will be diluted with an equal volume by adding distilled water.\n\nThe child will be seated in an upright position on the dental chair. Before placing the mask of the nebulizer, the child will be coached into proper breathing pattern', 'armGroupLabels': ['Nebulized Midazolam']}, {'name': 'Intranasal Midazolam', 'type': 'DRUG', 'description': 'All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child, For children who will receive midazolam using the atomization device attached to a three-ml syringe, the child sitting reclined in knee-to-knee position. Half of the dose will be sprayed in the right nostril and the other half will be sprayed in the left nostril to double the absorptive surface area by short and quick puffs', 'armGroupLabels': ['Intranasal Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Amira A ElKhatib, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University, Kafrelsheikh, Egypt'}, {'name': 'Yousr Nader, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}