Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Not Applicable

Completed

• Conditions: Extrusion of Tooth
• Interventions: Drug: Midazolam; Drug: Propranolol

• Registration Number: NCT03388957
• Lead Sponsor: Damascus University

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.

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 Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-31
• Study First Posted: 2018-01-03
• Study Start: 2018-07-30
• Primary Completion: 2019-10-01
• Study Completion: 2020-02-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-20
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Anxiety-1 levels	(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)
Change in Anxiety-2 levels	(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)
Change in heart rate	(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

Secondary Outcome Measures

Name	Time	Method
Change in Behavior	(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)

Trial Locations

Locations (1)

Department of Peadodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic