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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 March 2021 |
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Main ID: |
NCT03388957 |
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Date of registration:
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18/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Oral Propranolol for Reducing Pediatric Dental Patients Anxiety
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Scientific title:
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Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial |
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Date of first enrolment:
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July 30, 2018 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03388957 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Youssef Latifeh, MD MSc Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria |
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Name:
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Mohamed Altinawi, DDS MSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA |
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Name:
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Omar Abu Bakr, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria |
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Key inclusion & exclusion 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.
Age minimum:
8 Years
Age maximum:
10 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Extrusion of Tooth
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Intervention(s)
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Drug: Propranolol
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Drug: Midazolam
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Primary Outcome(s)
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Change in Anxiety-2 levels
[Time Frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction.]
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Change in Anxiety-1 levels
[Time Frame: (1) five minutes before medication, (2) 30 minutes post-extraction]
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Change in heart rate
[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]
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Secondary Outcome(s)
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Change in Behavior
[Time Frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction]
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Secondary ID(s)
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UDDS-Pedo-02-2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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