Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, 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
- Quality of anesthesia
研究概览
简要总结
The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.
详细描述
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory drugs (NSAIDS). 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 present study aims to evaluate in a double blind, randomized and cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. The following parameters will be analyzed: 1) subjective postoperative pain evaluation, with the aid of a visual analogue scale, 2) mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal), 3) beginning and duration of the surgery after anesthetic administration, 4) incidence, type and severity of adverse reactions, 5) total amount of rescue analgesic medication (paracetamol), 6) facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery). The comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both NSAIDS.
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 Naproxen
Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg.
干预措施: Surgery with Naproxen (Drug)
Surgery with Naproxen and Esomeprazole
Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg and esomeprazole 20mg.
干预措施: Surgery with Naproxen and Esomeprazole (Drug)
结局指标
主要结局
Quality of anesthesia
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.
Heart rate
时间窗: During the surgical procedure
Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Intraoperative bleeding
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.
Blood pressure
时间窗: During the surgical procedure
Systolic blood pressure, diastolic, and mean 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.
Evaluation of postsurgical pain
时间窗: Seventh postoperative day
Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) and total amount (mg) of rescue medication consumption in the postoperative period. The subjective pain evaluations will be performed by patients at the following times after administration of the drugs \[0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h\].
Oxygen saturation
时间窗: During the surgical procedure
Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
次要结局
- Total amount of rescue medication(Seventh postoperative day)
- Onset and duration of surgery after administration of anesthetic(During the surgery)
- Postoperative mouth opening(Second and Seventh postoperative days)
- Incidence, type and severity of adverse reactions(Seventh postoperative day)
- Measurement the facial edema(On the second day after surgery and on the seventh day after surgery.)
研究者
Giovana Maria Weckwerth
DDS
University of Sao Paulo