Anxiety and Pain
Conditions
Interventions
A total of twenty patients both genders, fifteen women and five men participated in the study. The volunteers were randomized in two groups (Alprazolam and Placebo). Each patient underwent two surgica
Drug
Procedure/surgery
Behavioural
D03.438.079.080.030
Sponsors
Faculdade de Odontologia da Universidade Federal do Pará
Faculdade de Odontologia da Universidade Federal do Pará
Eligibility
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria comprised ASA I patients(according to American Society of Anesthesiology; both genders; ranging from 18 to 45 years old and who needed bilateral maxillary and mandibular third molars extraction
Exclusion criteria
Exclusion criteria: The exclusion criteria comprised presence of systemic changes (ASA III or IV patients); history of hypersensitivity or allergies to benzodiazepines; recent use of benzodiazepines; pregnancy; dependency on narcotic drugs; narrow-angle glaucoma; alcoholism and patients under chronic use of sedatives or analgesics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: Significant changes in at least one of the three the cardiovascular variables (e.g. arterial blood pressure (ABP), peripheral capillary oxygen saturation (SPO2) and heart rate (HR)) as well as dental anxiety and pain, related to ambulatory third molars surgeries, driven by 0.5 mg Alprazolam but not with a placebo treatment.;Obtained outcome: The objective assessment of the medication’s effect revealed that, during the surgical procedures, the ABP was maintained within the normal levels in both groups. The statistical analysis revealed no significant difference in the ABP between the first and second surgical times (p =0, 2047). In addition, the statistical analysis also showed no difference of SPO2 between first and second surgical times (p = 0, 1764). The average of SPO2 in the preoperative, transoperative and post-operative periods of the first and second surgical times was 98%. Conversely, the median of HR for subjects treated with alprazolam was 80.61 and for subjects treated with placebo was 86.75. The statistical analysis revealed a statiscally significant difference of HR between the first and second surgical times (p = 0,007). None of the subjective variables analyzed demonstrated statistically significant differences between the two groups studied (e.g. alprazolam and placebo). Nonetheless, the data suggest obtained suggests beneficial effects of alprazolam over the placebo treatment. A self-perception of anxiety was lower when surgery was performed under the effect of alprazolam, before and after the procedure, when compared to placebo. In addition, the subjects reported that they felt more comfortable during the transoperative period (p=0,024) under the effect of alprazolam than under the effect of placebo. The impression of the surgery complexity showed that the majority of the subjects considered the procedure simpler when in the alprazolam cohort than in the placebo group. Furthermore, the subects’ impressions regarding the dura | — |
Secondary
| Measure | Time frame |
|---|---|
| Obtained outcome: Two out of the twenty-two patients that were initially recruited to participate in the study were excluded from the sample after their clinical and laboratory tests revealed systemic diseases. Therefore, twenty patients, 5 males and 15 females, ranging from 18 to 45 years old underwent their planned surgical procedure and received the allocated study drug. None of the enrolled patients dropped out of the study. All patients tolerated the procedures well and without significant side effects or complications related to the procedures or the medication administrated. None of the subjects reported nausea during the surgical procedure and no signs of hypotension or respiratory failure were detected. The mean duration of the surgery was 60 minutes. There was no significant difference in the duration of the surgical intervention between alprazolam and placebo groups.;Expected outcome: Reliability of simple self-perception questionnaire developed to evaluate the subjective variables investigated in this study.;Obtained outcome: The influence of alprazolam and placebo treatments over dental anxiety and pain were verified through subjective variables identified by subjects in a self-perception questionnaire, developed to this study. This questionnaire was applied immediately after each surgical procedure. Subjects needed to answer six questions about the levels of anxiety, surgical time, complexity of the procedure and painful symptomatology. A simple test was used to evaluate amnesia during the procedure through the questions 4 and 5 of the questionnaire. Patients were instructed to record the pain experience using a numerical pain scale, ranging from 0 to 10. Pain score were categorized as “none”, “mild”, “moderate” or “severe” using previously established criteria. zero score on the numerical pain scale being regarded as “no pain”, 1-3 as “mild” pain, 4-6 as “moderate” pain and 7-10 as “severe”. ;Expected outcome: Confirmation of the beneficial | — |
Countries
Brazil
Contacts
Public ContactDanielle Martins
Faculdade de Odontologia da Universidade Federal do Pará
Outcome results
None listed