Status:
COMPLETED
Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
Lead Sponsor:
Damascus University
Conditions:
Extrusion of Tooth
Eligibility:
All Genders
8-10 years
Phase:
NA
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 anxie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03388957
Start Date
July 30 2018
End Date
February 15 2020
Last Update
March 24 2021
Active Locations (1)
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1
Department of Peadodontics, University of Damascus Dental School
Damascus, Syria, DM20AM18