Extrusion of Tooth
Conditions
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.
Interventions
DRUGMidazolam
This drug will be given before the extraction procedure
DRUGPropranolol
This drug will be given before the extraction procedure
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Three groups, with 20 children in each group
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Syria
Outcome results
None listed