Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subjective evaluation of postsurgical pain
研究概览
简要总结
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal anti-inflammatory drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg omeprazole) in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. After collection, data will be analyzed by means of graphs and tables to allow the appropriate analyses. Paired t-test will be used to compare the duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening" and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results will be presented as mean ± standard deviation of the mean.
详细描述
Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The protocol for the administration of these formulations will involve the administration of a tablet of the immediate release product (100 mg) every 12 hours, and one capsule of the modified release product (200 mg ketoprofen with omeprazole) every 24 hours, during 4 days.
The following parameters will be analyzed:
- subjective postoperative pain evaluation, with the aid of a visual analogue scale,
- mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal),
- beginning and duration of the surgery after anesthetic administration,
- incidence, type and severity of adverse reactions,
- total amount of rescue analgesic medication (paracetamol),
- facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need of lower third molar surgeries in similar positions
排除标准
- •Presence of systemic diseases;
- •Presence of local inflammation and/or infection;
- •Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- •Cardiovascular, kidney or hepatic diseases;
- •Patients who are making use of antidepressants, diuretics or anticoagulants;
- •Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug;
- •Regular use of any nonsteroidal antiinflammatory drug, pregnancy or breast feeding.
研究组 & 干预措施
Surgery with Ketoprofen
Fifty healthy volunteers underwent removal one of lower third molar, will be treated to control pain, swelling and trismus with ketoprofen 100 mg
干预措施: Ketoprofen (Drug)
Surgery with Ketoprofen and Omeprazole
Fifty healthy volunteers underwent removal the other lower third molars, will be treated to control pain, swelling and trismus with ketoprofen 200 mg associated with Omeprazole 20 mg
干预措施: Ketoprofen and Omeprazole (Drug)
结局指标
主要结局
Subjective evaluation of postsurgical pain
时间窗: Fourth postoperative hour
Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) at the fourth postoperative hour.
Quality of anesthesia during surgery based on a category 3point scale
时间窗: During the surgical procedure
Quality of anesthesia during surgery based on a category 3point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale
时间窗: During the surgical procedure
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale (1 minimal bleeding; 2 normal bleeding; 3 excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Heart rate
时间窗: During the surgical procedure
Median heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters
Oxygen saturation
时间窗: During the surgical procedure
Median oxygen saturation recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Systolic blood pressure
时间窗: During the surgical procedure
Median systolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
Diastolic blood pressure
时间窗: During the surgical procedure
Median diastolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
次要结局
- Incidence, type and severity of adverse reactions(Seventh postoperative day)
- Total amount of rescue medication(Seventh postoperative day)
- Measurement the facial edema distance between the lateral corner of the eye and the gonion, away from the tragus corner of the mouth and away from the tragus to the soft tissue of pogonion.(On the second day after surgery and on the seventh day after surgery)
- Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws(Second and Seventh postoperative days)
- Onset and duration of surgery after administration of anesthetic(During the surgery)
研究者
Luis Fernando Simoneti
DDS
University of Sao Paulo