Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
NCT ID: NCT03388957
Last Updated: 2021-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-07-30
2020-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Propranolol
Patients in this group will be given Propranolol 0.5 mg/Kg orally.
Propranolol
This drug will be given before the extraction procedure
Midazolam
Patients in this group will be given Midazolam 0.5 mg/Kg orally.
Midazolam
This drug will be given before the extraction procedure
Propranolol and Midazolam
Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.
Propranolol
This drug will be given before the extraction procedure
Midazolam
This drug will be given before the extraction procedure
Interventions
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Propranolol
This drug will be given before the extraction procedure
Midazolam
This drug will be given before the extraction procedure
Eligibility Criteria
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Inclusion Criteria
* Scoring more than 19 points on MCDAS(f).
* Healthy pediatric patients (ASA I) aging 8-10 years.
* Indication for primary tooth or molar extraction.
* Fasting if indicated (severe gag reflex).
* Airway assessment (Mallampati and tonsillar hypertrophy).
Exclusion Criteria
* Cardiac failure.
* Cardiac arrhythmia.
* Renal failure.
* Diabetes.
* Current use of another ß-adrenoreceptor antagonist.
* Current use of anxiolytic or antidepressant medication.
* Currently in psychotherapy for dental anxiety.
* Systolic blood pressure \<100 mmHg.
* Diastolic blood pressure \<60 mmHg.
* Active Upper respiratory infection.
8 Years
10 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Omar Abu Bakr, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Mohamed Altinawi, DDS MSc PhD
Role: STUDY_CHAIR
Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
Youssef Latifeh, MD MSc Phd
Role: STUDY_DIRECTOR
Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria
Locations
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Department of Peadodontics, University of Damascus Dental School
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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UDDS-Pedo-02-2017
Identifier Type: -
Identifier Source: org_study_id
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