Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 4:04 AM
Study NCT ID:
NCT03388957
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2017-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups, with 20 children in each group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-20', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-31', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Anxiety-1 levels', 'timeFrame': '(1) five minutes before medication, (2) 30 minutes post-extraction', 'description': "Anxiety-1 levels will be evaluated using self-reported faces anxiety scale (also called 'modified child dental anxiety scale). Scale name: Modified Child Dental Anxiety Scale (MCDAS):\n\n1. Relaxed/Not worried. (Better outcome)\n2. Very slightly worried.\n3. Fairly worried.\n4. Worried a lot.\n5. Very worried. (Worse outcome)"}, {'measure': 'Change in Anxiety-2 levels', 'timeFrame': '(1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction.', 'description': 'Anxiety-2 levels will be measured using Observational Venham Anxiety Scale\n\nMajor Issues: 1) Will be measured in 2 phases:\n\n* 45 minutes after medication, while applying local anesthesia.\n* While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome)\n\n 1. Uneasy.\n 2. Tense.\n 3. Reluctant.\n 4. Interference.\n 5. Out of contact. (Worse outcome)'}, {'measure': 'Change in heart rate', 'timeFrame': '(1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction', 'description': 'using Finger Pulse Oximeter'}], 'secondaryOutcomes': [{'measure': 'Change in Behavior', 'timeFrame': '(1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction', 'description': 'using Observational Frankl Scale "Frankl Scale":\n\n1. Definitely negative. (Worse outcome)\n2. Negative.\n3. Positive.\n4. Definitely positive. (Better outcome)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extrusion of Tooth']}, 'referencesModule': {'references': [{'pmid': '27354454', 'type': 'BACKGROUND', 'citation': 'Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.'}, {'pmid': '27330369', 'type': 'BACKGROUND', 'citation': 'Gazal G, Fareed WM, Zafar MS, Al-Samadani KH. Pain and anxiety management for pediatric dental procedures using various combinations of sedative drugs: A review. Saudi Pharm J. 2016 Jul;24(4):379-85. doi: 10.1016/j.jsps.2014.04.004. Epub 2014 Apr 26.'}, {'pmid': '20151608', 'type': 'BACKGROUND', 'citation': 'Heaton LJ, McNeil DW, Milgrom P. Propranolol and D-cycloserine as adjunctive medications in reducing dental fear in sedation practice. SAAD Dig. 2010 Jan;26:27-35.'}, {'pmid': '27575676', 'type': 'BACKGROUND', 'citation': 'LeCompte MT, Rae L, Kahn SA. A survey of the use of propranolol in burn centers: Who, what, when, why. Burns. 2017 Feb;43(1):121-126. doi: 10.1016/j.burns.2016.07.007. Epub 2016 Aug 27.'}, {'pmid': '26487439', 'type': 'BACKGROUND', 'citation': 'Steenen SA, van Wijk AJ, van der Heijden GJ, van Westrhenen R, de Lange J, de Jongh A. Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. J Psychopharmacol. 2016 Feb;30(2):128-39. doi: 10.1177/0269881115612236. Epub 2015 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.', 'detailedDescription': 'Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).\n* Scoring more than 19 points on MCDAS(f).\n* Healthy pediatric patients (ASA I) aging 8-10 years.\n* Indication for primary tooth or molar extraction.\n* Fasting if indicated (severe gag reflex).\n* Airway assessment (Mallampati and tonsillar hypertrophy).\n\nExclusion Criteria:\n\n* Asthma or any other obstructive pulmonary disease.\n* Cardiac failure.\n* Cardiac arrhythmia.\n* Renal failure.\n* Diabetes.\n* Current use of another ß-adrenoreceptor antagonist.\n* Current use of anxiolytic or antidepressant medication.\n* Currently in psychotherapy for dental anxiety.\n* Systolic blood pressure \\<100 mmHg.\n* Diastolic blood pressure \\<60 mmHg.\n* Active Upper respiratory infection.'}, 'identificationModule': {'nctId': 'NCT03388957', 'briefTitle': 'Oral Propranolol for Reducing Pediatric Dental Patients Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'UDDS-Pedo-02-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propranolol', 'description': 'Patients in this group will be given Propranolol 0.5 mg/Kg orally.', 'interventionNames': ['Drug: Propranolol']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam', 'description': 'Patients in this group will be given Midazolam 0.5 mg/Kg orally.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Propranolol and Midazolam', 'description': 'Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.', 'interventionNames': ['Drug: Propranolol', 'Drug: Midazolam']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': 'This drug will be given before the extraction procedure', 'armGroupLabels': ['Propranolol', 'Propranolol and Midazolam']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'This drug will be given before the extraction procedure', 'armGroupLabels': ['Midazolam', 'Propranolol and Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DM20AM18', 'city': 'Damascus', 'country': 'Syria', 'facility': 'Department of Peadodontics, University of Damascus Dental School', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Omar Abu Bakr, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria'}, {'name': 'Mohamed Altinawi, DDS MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA'}, {'name': 'Youssef Latifeh, MD MSc Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}