Clinical Pharmacogenetic of Ibuprofen Enantiomers After Lower Third Molar Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of changes in the postsurgical pain during the first 24 hours until 96 hours after the procedure
研究概览
简要总结
The present clinical trial randomized will be to assess the link between the different haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower third molar extractions. 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, 200 healthy volunteers underwent removal of one lower third molar, under local anesthesia with articaine 4% (1:200,000 adrenaline) will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population.
详细描述
The aim of this study will be to assess the link between the different haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower third molar extractions regarding pain, swelling and trismus, adverse reactions, the amount of pain medication used, the patient satisfaction with the drug and the influence of the ability on preoperative modulation of conditioned pain. We will evaluate also the relationship between the different haplotypes of OPRM1 gene (SNP A118G), the salivary concentrations of pro-inflammatory cytokines (IL-2, IL-4, IL-6, IL-10 and TNF-±), and preoperative conditioned pain modulation. Therefore, 200 patients will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population.
For analysis of the proposed genes, saliva will be collected, which will serve as a source of genomic DNA. For molecular analysis it will be performed polymerase chain reaction (PCR). All tests will be conducted and validated by Applied Biosystems®. Also it will be held in the research, genetic sequencing of the genes CYP2C8, CYP2C9 and OPRM1, to verify possible correlations of these genes with postoperative pain and pain modulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need of lower third molar surgeries
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, ibuprofen or any other nonsteroidal antiinflammatory drug;
- •Regular use of any nonsteroidal antiinflammatory drug,
- •Pregnancy or breast feeding.
研究组 & 干预措施
Experimental Group Ibuprofen 600mg
Two Hundred healthy volunteers underwent removal of one lower third molar, will be treated to control pain, swelling and trismus with ibuprofen 600mg. Therefore, these 200 patients will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population.
干预措施: Ibuprofen 600 mg (Drug)
结局指标
主要结局
Evaluation of changes in the postsurgical pain during the first 24 hours until 96 hours after the procedure
时间窗: Seventh postoperative day
Subjective evaluation of postsurgical pain, which was annotated by the volunteer after the surgery, in a Visual Analogue Scale (VAS, 0-100 mm). The subjective pain evaluations will be performed by patients at the following times after administration of the drug \[0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h\]. What will be taken into account on this outcome is the representation of the postsurgical pain, that will be noted on the Visual Analogue Scale (in millimeters) in respective moments.
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.
Intraoperative bleeding during the surgeries steps
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 variability during the surgeries steps
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.
Heart rate variability during the surgeries steps
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.
Oxygen saturation variability during the surgeries steps
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.
Subjective evaluation of postsurgical pain at the moment of the rescue medication utilization
时间窗: Seventh postoperative day
Subjective evaluation of postsurgical pain at the moment of the rescue medication consumption which was annotated by the volunteer after the surgery, in a Visual Analogue Scale (VAS, 0-100 mm).
次要结局
- Postoperative mouth opening(Second and Seventh postoperative days)
- Onset and duration of surgery after administration of local anesthetic(During the surgery)
- Incidence, type and severity of adverse reactions after the surgery(Seventh postoperative day)
- Total amount of rescue medication(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, PhD student, Principal Investigator
University of Sao Paulo