Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Damascus University

Status: Completed

Conditions: Extrusion of Tooth

Treatments: Drug: Midazolam; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03388957

UDDS-Pedo-02-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 8 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Propranolol

Experimental group

Description:

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

Treatment:

Drug: Propranolol

Midazolam

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Propranolol and Midazolam

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: Propranolol