Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Extrusion of Tooth

Intervention / Treatment
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* Drug: Propranolol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups, with 20 children in each group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br>Patients in this group will be given Propranolol 0.5 mg/Kg orally. | Drug: Propranolol<br>* This drug will be given before the extraction procedure<br>|
| Experimental: Midazolam<br>Patients in this group will be given Midazolam 0.5 mg/Kg orally. | Drug: Midazolam<br>* This drug will be given before the extraction procedure<br>|
| Experimental: Propranolol and Midazolam<br>Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug. | Drug: Propranolol<br>* This drug will be given before the extraction procedure<br>Drug: Midazolam<br>* This drug will be given before the extraction procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |