Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-02 @ 5:21 PM
Study NCT ID:
NCT00902395
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Moderate Sedation for Dental Treatment of Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-15', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old", 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': "Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization", 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preschool children'], 'conditions': ['Dental Caries', 'Child Behavior', 'Conscious Sedation Failure During Procedure']}, 'referencesModule': {'references': [{'pmid': '22631626', 'type': 'RESULT', 'citation': 'Moreira TA, Costa PS, Costa LR, Jesus-Franca CM, Antunes DE, Gomes HS, Neto OA. Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. Int J Paediatr Dent. 2013 May;23(3):207-15. doi: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.'}]}, 'descriptionModule': {'briefSummary': 'There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.', 'detailedDescription': "There is a lack of clinical trials on pediatric dental sedation in children 3 years old and under. We investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation. Healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective stabilization without sedative (PS). One observer scored children's behavior using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analyzed using non-parametric bivariate tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children (ASA PS 1)\n* Children under 36 months old\n* Children presenting early childhood caries\n* Children with no history of dental treatment\n\nExclusion criteria:\n\n* Lost to follow-up'}, 'identificationModule': {'nctId': 'NCT00902395', 'briefTitle': 'Efficacy of Moderate Sedation for Dental Treatment of Young Children', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Goias'}, 'officialTitle': 'Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children', 'orgStudyIdInfo': {'id': 'UFG SAP 18189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Oral midazolam', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam/ketamine', 'description': 'Combined midazolam and ketamine', 'interventionNames': ['Drug: Midazolam, ketamine']}, {'type': 'OTHER', 'label': 'Protective stabilization', 'description': 'No drug or placebo administered', 'interventionNames': ['Behavioral: Protective stabilization']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormire, Cristalia, Sao Paulo, Brazil'], 'description': 'Oral midazolam 1.0 mg/kg (maximum 20 mg)', 'armGroupLabels': ['Midazolam']}, {'name': 'Protective stabilization', 'type': 'BEHAVIORAL', 'otherNames': ['No drug administered'], 'description': 'Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.', 'armGroupLabels': ['Protective stabilization']}, {'name': 'Midazolam, ketamine', 'type': 'DRUG', 'otherNames': ['Dormire, Cristalia, Sao Paulo, Brazil', 'Ketamin S+, Cristalia, Sao Paulo, Brazil'], 'description': 'Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)', 'armGroupLabels': ['Midazolam/ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74605220', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Dental School', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'Luciane R Costa, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Federal University of Goias'}, {'name': 'Paulo S Sucasas, MD, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School, Federal University of Goias'}, {'name': 'Thiago A C Moreira, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Health Sciences Graduate Program, UFG'}, {'name': 'Denise E Antunes, DDS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Health Sciences Graduate Program, UFG'}, {'name': 'Cristiana M Jesus-Franca, DDS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Health Sciences Graduate Program, UFG'}, {'name': 'Hugo S G Oliveira, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Health Sciences Graduate Program, UFG'}, {'name': 'Onofre A Neto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, UFG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Goias', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Faculty of Dentistry', 'investigatorFullName': 'Luciane Ribeiro de Rezende Sucasas da Costa', 'investigatorAffiliation': 'Universidade Federal de Goias'}}}}