Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Damascus University60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Extrusion of Tooth

Interventions

PropranololDRUG

This drug will be given before the extraction procedure

MidazolamDRUG

This drug will be given before the extraction procedure

Eligibility

Sex: ALLMin age: 8 YearsMax age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Peadodontics, University of Damascus Dental School

Damascus, Syria

Outcomes

Primary Outcomes

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)

Time frame: (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)

Time frame: (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

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

Secondary Outcomes

Change in Behavior

using Observational Frankl Scale "Frankl Scale": 1. Definitely negative. (Worse outcome) 2. Negative. 3. Positive. 4. Definitely positive. (Better outcome)

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

Data from ClinicalTrials.gov

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