Stomatognathic Diseases
Conditions
Interventions
51 volunteers with two third molars, with indication for dental extraction, will be selected. Each side from the same patient, to be operated, will be allocated to one of the groups of research:
-Gro
after taking the first dose, this medication will be repeated every 6 hours for 2 days.
-Group ketorolac plus tramadol 37.5 mg/paracetamol 325mg (Group B) - a pill of ketorolac 10 mg will be administ
Drug
Procedure/surgery
D03.438.473.420.485
A14.549.167.860.715
Sponsors
Universidade Estadual de Ponta Grossa
Universidade Estadual de Ponta Grossa
Eligibility
Inclusion criteria
Inclusion criteria: "Volunteers of both genders; aged 18 to 35 who have indication of third molar elective extraction and look for treatment at the clinic of Dentistry; State University of Ponta Grossa. Each patient should have two impacted third molars in a similar position; symmetrical bilaterally; according to Pell and Gregory and Miller Winter rating; and at least 1/3 of the formed root; according to radiographic evaluation; classified as class I or II, B and C Pell and Gregory. Patients must be healthy; without systemic changes and classified as ASA I; American Society of Anesthesiologist".
Exclusion criteria
Exclusion criteria: "Patients with a history of hypersensitivity to ketorolac; pregnancy; asthmatics; diabetics; lactation; hypertensive; patients with gastrointestinal disorders; myasthenia gravis or glaucoma are not included in the study. Immunosuppressed patients; dependent on narcotic drugs; patients with neurological and or behavioral changes; inflammatory users or antihypertensives continuously will also be excluded from the sample".
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: pain intensity. Patients will be instructed to write down the intensity of pain immediately, 3h, 6h, 9h, 12h, 24h and 48h after surgery on a VAS scale from 0 to 100 mm, in which 0 = no pain and 100 = worst pain possible. The VAS measures will be recorded over the period of research and compiled into a graph of pain (mm) versus time (in hours). The area under the graph (AUC) was measured using the trapezoidal method and recorded as AUC 0-24. This measure makes a global assessment of each patient's pain experience throughout the investigation time periods. Additionally, the worst measure of pain reported by patients in the trial period will be used to compare the groups. The worst score of pain intensity (obtained in different times) and the area under the graph in the two groups will be compared using a paired Student’s t-test. The comparison between the pain intensity in different times and groups were performed using an analysis of variance of two factors repeated measure. It was calculated the effect size (average difference), and the 95% confidence intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome: Assessment of medicine adverse effects. The patients will be asked to fill in their diary (paper note) the occurrence of some kind of adverse effects such as nausea, vomiting, diarrhea, dizziness, drowsiness and headache. These occurrences will be explicitly described in a form participants will have to fill in. They will also be instructed to record any other more uncommon occurrences as the long bleeding after surgery, kidney failure, and other gastrointestinal alterations. ;Expected outcome: Oral surgery self-perception assessment. This instrument interprets disturbances, perceptions and feelings of the patient during oral surgery. The evaluation of the self-perception of oral surgery has 20 questions to be answered on a scale of 0 (zero) to 10 (ten), where zero is no discomfort and ten the discomfort was extreme. ;Expected outcome : Average time for the rescue medication. It will be defined as the time from the end of the surgery until the time that the patient takes the rescue medication (paracetamol 500 mg). Patients will be instructed to record the time and check the pain intensity on the visual analogue score (VAS 100 mm) when taking the rescue medication. The data recorded in the two groups will be compared using a paired Student's t test. The effect size (average difference), and the 95% confidence intervals will be calculated similarly.;Expected outcome : Total amount of analgesic. Total amount of analgesic (acetaminophen tablets) consumed during the full recovery period (48 hs) was recorded.Every need of the intake of rescue medication, the patient will be instructed to note in his diary on a visual analog scale the pain intensity felt at that moment. The data recorded in the two groups will be compared using a paired Student’s t-test. The effect size (mean difference), and the 95% confidence intervals will be calculated similarly ;Expected outcome: global effect assessment. Patients should provide an overall evaluation o | — |
Countries
Brazil
Contacts
Public ContactAlessandra Loguercio
Universidade Estadual de Ponta Grossa
Outcome results
None listed