Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

NCT03388957 | Completed DMC

• 1 other identifier: UDDS-Pedo-02-2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Extrusion of Tooth

Outcome Measures

Primary Outcomes (3)

• 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): 1. Relaxed/Not worried. (Better outcome) 2. Very slightly worried. 3. Fairly worried. 4. Worried a lot. 5. Very worried. (Worse outcome)

  (1) five minutes before medication, (2) 30 minutes post-extraction

• 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) 1. Uneasy. 2. Tense. 3. Reluctant. 4. Interference. 5. 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.

• 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 Outcomes (1)

• Change in Behavior

  (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction

Study Arms (3)

Propranolol

EXPERIMENTAL

Patients in this group will be given Propranolol 0.5 mg/Kg orally.

Drug: Propranolol

Midazolam

EXPERIMENTAL

Patients in this group will be given Midazolam 0.5 mg/Kg orally.

Drug: Midazolam

Propranolol and Midazolam

EXPERIMENTAL

Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.

Drug: Propranolol; Drug: Midazolam

Interventions

Propranolol DRUG

This drug will be given before the extraction procedure

Propranolol; Propranolol and Midazolam

Midazolam DRUG

This drug will be given before the extraction procedure

Midazolam; Propranolol and Midazolam

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (5)

• 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: 27354454 BACKGROUND

• 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: 27330369 BACKGROUND

• 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: 20151608 BACKGROUND

• 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: 27575676 BACKGROUND

• 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.

  PMID: 26487439 BACKGROUND

MeSH Terms

Interventions

Propranolol; Midazolam

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Omar Abu Bakr, DDS

  MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohamed Altinawi, DDS MSc PhD

  Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA

  STUDY CHAIR

• Youssef Latifeh, MD MSc Phd

  Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups, with 20 children in each group

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 3, 2018
• Study Start: July 30, 2018
• Primary Completion: October 1, 2019
• Study Completion: February 15, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)