Extrusion of Tooth Clinical Trial
Official title:
Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
Verified date | March 2021 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 15, 2020 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Peadodontics, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Coté 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). pii: e20161212. doi: 10.1542/peds.2016-1212. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Anxiety-1 levels | 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): Relaxed/Not worried. (Better outcome) Very slightly worried. Fairly worried. Worried a lot. Very worried. (Worse outcome) |
(1) five minutes before medication, (2) 30 minutes post-extraction | |
Primary | Change in Anxiety-2 levels | Anxiety-2 levels will be measured using Observational Venham Anxiety Scale Major Issues: 1) Will be measured in 2 phases: 45 minutes after medication, while applying local anesthesia. While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome) Uneasy. Tense. Reluctant. Interference. Out of contact. (Worse outcome) |
(1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction. | |
Primary | Change in heart rate | using Finger Pulse Oximeter | (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 | Change in Behavior | using Observational Frankl Scale "Frankl Scale": Definitely negative. (Worse outcome) Negative. Positive. Definitely positive. (Better outcome) |
(1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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N/A |