Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT03728894
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2018-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Sedation With and Without Nitrous Oxide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple (Participant, Care Provider, Outcomes Assessor) Each of the children/parents, the dentist and the outcomes assessors were blinded. To ensure the blindness of the dentist, the inhalation sedation machine was placed in a way that he could not see the flow rate panel or the type of the administered gases.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'blinded, randomized controlled trial, comparing two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-05', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavior improvement on the modified Houpt behavioral rating scale', 'timeFrame': "Behavior will assess at the end of the session (about 30-90 min) by evaluating the sessions 's videotapes using overall assessment (range from 1 to 4, higher values represent a better outcome) of the modified Houpt behavioral rating scale", 'description': 'Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.'}, {'measure': 'Behavior improvement on the modified Houpt behavioral rating scale', 'timeFrame': "Behavior assess after 30 min of oral medications administered by evaluate the sessions's videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale", 'description': 'Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midazolam', 'hydroxyzine', 'oxygen', 'behavior', 'child', 'tooth'], 'conditions': ['Behavior, Child']}, 'descriptionModule': {'briefSummary': 'Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.', 'detailedDescription': 'The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria: Inclusion Criteria:\n\n* ASA Classification I.\n* minimum weight of 18 kg\n* uncooperative children scored 1 or 2 on Frankle Scale.\n* requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.\n\nExclusion Criteria:\n\n* known allergy to midazolam and/or hydroxyzine.\n* upper respiratory tract infection with nasal discharge.'}, 'identificationModule': {'nctId': 'NCT03728894', 'briefTitle': 'Oral Sedation With and Without Nitrous Oxide', 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University'}, 'officialTitle': 'Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients', 'orgStudyIdInfo': {'id': 'Tishreen-sedation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: Midazolam-hydroxyzine with 100% O2', 'description': 'Midazolam-hydroxyzine with 100% O2 was administrated to 30 children. Drug: Oral Medication (midazolam 7.5 mg and hydroxyzine 10 mg) and Inhalation Gas 100% O2 Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.', 'interventionNames': ['Drug: Midazolam-hydroxyzine with 100% O2']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam-hydroxyzine with 50% N2O/ O2', 'description': 'children received Midazolam-hydroxyzine with 50% N2O/O2, one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2. Drug: Oral Medication and Inhalation Gas Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.', 'interventionNames': ['Drug: Midazolam-hydroxyzine with 50% N2O/O2']}], 'interventions': [{'name': 'Midazolam-hydroxyzine with 100% O2', 'type': 'DRUG', 'otherNames': ['A'], 'description': 'Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.', 'armGroupLabels': ['A: Midazolam-hydroxyzine with 100% O2']}, {'name': 'Midazolam-hydroxyzine with 50% N2O/O2', 'type': 'DRUG', 'otherNames': ['B'], 'description': 'Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.', 'armGroupLabels': ['Midazolam-hydroxyzine with 50% N2O/ O2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Latakia', 'country': 'Syria', 'facility': 'Tishreen University', 'geoPoint': {'lat': 35.53125, 'lon': 35.79088}}], 'overallOfficials': [{'name': 'Nabih Raslan, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Tishreen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'up to date, there is no decision about IPD sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nabih Raslan', 'investigatorAffiliation': 'Tishreen University'}}}}