CompletedNot Applicable

Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Syria60 participantsStarted 2018-07-30

Plain-language 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.

Who can participate

Age range

8 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Anxiety-1 levels

Timeframe: (1) five minutes before medication, (2) 30 minutes post-extraction

Change in Anxiety-2 levels

Timeframe: (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

Timeframe: (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

Trial details

NCT IDNCT03388957

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-01

View on ClinicalTrials.gov More Extrusion of Tooth trials