Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

March 20, 2021 updated by: Damascus University

Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Peadodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propranolol
Patients in this group will be given Propranolol 0.5 mg/Kg orally.
Drug: Propranolol
This drug will be given before the extraction procedure
Experimental: Midazolam
Patients in this group will be given Midazolam 0.5 mg/Kg orally.
Drug: Midazolam
This drug will be given before the extraction procedure
Experimental: 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.
Drug: Propranolol
This drug will be given before the extraction procedure
Drug: Midazolam
This drug will be given before the extraction procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety-1 levels
Time Frame: (1) five minutes before medication, (2) 30 minutes post-extraction

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

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
Time Frame: (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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Behavior
Time Frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction

using Observational Frankl Scale "Frankl Scale":

  1. Definitely negative. (Worse outcome)
  2. Negative.
  3. Positive.
  4. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Omar Abu Bakr, DDS, MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
  • Study Chair: Mohamed Altinawi, DDS MSc PhD, Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
  • Study Director: Youssef Latifeh, MD MSc Phd, Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 31, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 20, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-02-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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