Pain. Conscious Sedation. Dental Anxiety
Conditions
Interventions
40 Patients will be randomized and allocated into two different groups. As this is a “split-mouth” clinical trial, the lower posterior quadrants are considered individual experimental units, where one
E03.091
Sponsors
Faculdade de Odontologia de Pernambuco, Universidade de Pernambuco - UPE
Faculdade de Odontologia de Pernambuco, Universidade de Pernambuco - UPE
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Adult patients aged between 18 and 40 years, of both sexes, of any ethnicity, healthy, do not report reactions or allergic processes to the drugs used in the research or their components and who are not using any other medication. All patients must have both lower third molars, right and left, partially or totally included, with the same pattern of positioning and root formation, according to the Pell & Gregory classification, healthy and with an indication for extraction. All patients must agree to the research and sign the Free and Informed Consent Form - TCLE
Exclusion criteria
Exclusion criteria: Patients with pathological lesions associated with lower third molar teeth will be excluded from the research; those who are unable to open their mouths for the surgery; patients with pericoronitis in the acute or chronic phase; recent history of head and neck chemotherapy and/or radiotherapy; use of medications that have a known interaction with pregabalin or other drugs used; smokers, pregnant or lactating patients; patients using oral contraceptives; diabetics; patients with congestive heart failure; hereditary problems of galactose intolerance; patients who do not return for postoperative follow-up within the established deadlines; those who gave up participating in the research at some point; do not perform the requested exams; have renal or liver failure; allergic to any drug used in the study; surgeries that exceed 40 minutes; present postoperative infection; and patients who do not sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess pain through the Visual Analogue Scale (VAS) which is the most widely used resource in the literature. The VAS is a ruler-shaped scale with 11 points that represents the sensation of painful intensity, where 0 is the absence of pain and 10 is the most acute pain. The scores will be interpreted as follows: total absence of pain: 0; mild pain: 1 to 3; moderate pain: 4 to 6; severe pain: 7 to 10. This allows the patient to describe their discomfort more objectively. Patients will be instructed to complete the VAS assessment form at different times in the postoperative period, starting in the first 30 minutes after surgery and consequently at the following intervals: 2h, 4h, 6h, 8h, 12h, 16h, 24h, 48h and 72h , according to the pain assessment form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess anxiety in two different and complementary ways. To this end, we will use subjective and objective parameters. The subjective assessment will use the State-Trait Anxiety Inventory (STAI) instrument, the Modified Dental Anxiety Scale (MDAS) and the Visual Analogue Scale (VAS) for anxiety. The STAI-T questionnaire will be applied at the time of the initial consultation for all patients. The STAI-E questionnaire will be applied at two different times for each patient: one at the initial consultation and the other 1 hour after the patient ingests the medications of each selected group. The MDAS is a modification of the Corah Anxiety Scale (Corah Dental Anxiety Scale) with an additional question about anxiety at the time of local anesthesia. The scale consists of 5 questions and 5 response options on the Likert scale, with scores ranging from 5 to 25, with 0 to 5 (not anxious); 6 to 10 (little anxious); 11 to 14 (moderately anxious); 15 to 18 (very anxious); 19 to 25 (extremely anxious). The questionnaire will be applied at the initial consultation to classify patients according to the degree of anxiety. The VAS will be used to complement the subjective assessment and allow the measurement of situations that cannot be measured by oral or written language. A 100 mm scale will be used with 11 points, ranging from 0 (no anxiety) to 10 (maximum anxiety).78 The scores will be interpreted as follows: mild anxiety: 0 to 2; moderate anxiety: 3 to 7; intense anxiety: 8 to 10. Patients will categorize anxiety on the scale in two moments: at the initial consultation and again 1 hour after the patient ingests the medications of each selected group. The objective assessment will be made through the analysis of hemodynamic changes in patients at different times. Signs will be measured such as: blood pressure (systolic and diastolic and mean blood pressure), expressed in millimeters of mercury (mmHg); heart rate (HR), measured in beats per minute (bpm); and oxygen saturation | — |
Countries
Brazil
Contacts
Public ContactJiordanne Diniz
Faculdade de Odontologia de Pernambuco, Universidade de Pernambuco - UPE
Outcome results
None listed