Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388957
• Other study ID #: UDDS-Pedo-02-2017
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: March 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Extrusion of Tooth

Intervention

Drug:
• Propranolol
This drug will be given before the extraction procedure
• Midazolam
This drug will be given before the extraction procedure

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Peadodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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

Outcome

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