Clinical trial NCT03388957: Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
Official title: Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extrusion of Tooth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups, with 20 children in each group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
* 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:

* Asthma or any other obstructive pulmonary disease.
* 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.

Primary outcomes:
measure: Change in Anxiety-1 levels
timeFrame: (1) five minutes before medication, (2) 30 minutes post-extraction
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.
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Peadodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
name: Omar Abu Bakr, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
name: Mohamed Altinawi, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria
name: Youssef Latifeh, MD MSc Phd
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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.