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临床试验/NCT00841841
NCT00841841已完成2 期

Dipyrone Versus Acetaminophen in the Control of Postoperative Pain

University Center of Araraquara0 个研究点目标入组 30 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
主要终点
Pain control with analgesics drugs

研究概览

简要总结

Adequate postoperative pain management is challenging for practitioners despite recent advances in pain control techniques and analgesic agents. The purpose of this study is to compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar surgery.

详细描述

Thirty patients scheduled for surgical removal of impacted third molars at the Discipline of Oral and Maxillofacial Surgery and Traumatology of the Dental School of Araçatuba, São Paulo State University, Brazil, were selected for the study after review and approval of the research protocol by the institutional Research Ethics Committee (Protocol #2006-01083). All patients received verbal and written explanations about the study purposes and procedures, and all of them signed an informed consent form prior to enrollment.

Patients should be in good general health and those who fulfilled any of the following criteria were excluded: systemic disorders; known hypersensitivity to any of the study medications; pregnancy or nursing; local contraindication to surgery as judged by the oral surgeon; and use of any analgesic agent 24 hours before surgery.

All patients were premedicated with oral dexamethasone 4 mg one hour before surgery for modulation of the postoperative edema. The surgical procedures were performed by a single operator according to a standardized surgical protocol and in compliance with all principles of the surgical technique. All patients received standard verbal and written postoperative instructions regarding diet, oral hygiene and general care.

The patients were randomly assigned to 2 groups of 15 patients, according to the drug prescribed as postoperative medication: Group I: dipyrone 500 mg every 6 hours (4 males, 11 females, mean age = 25.2 years) and Group II: paracetamol 750 mg every 6 hours (3 males, 12 females, mean age = 26.8 years). Amoxicillin 500 mg was prescribed for all patients. All surgeries were completed within 1 hour and were performed under local anesthesia with injection of an average volume of 3.6 mL of 2% mepivacaine with 1:100,000 adrenaline per surgical site. No relevant perioperative complications were observed.

In Group I, 3 maxillary right third molars, 9 maxillary left third molars, 10 mandibular left third molars and 9 mandibular right third molars were extracted. The following impaction positions were observed: vertical (n=22), horizontal (n=4) and medio-angulated (n=4). During surgery, osteotomy was necessary in 2 surgical sites and osteotomy associated with tooth sectioning was required in 8 cases. In Group II, 1 maxillary right third molar, 9 maxillary left third molars, 12 mandibular left third molar and 3 mandibular right third molars were extracted. The following impaction positions were observed: vertical (n=18), horizontal (n=2) and medio-angulated (n=3). During surgery, osteotomy, tooth sectioning and osteotomy associated with tooth sectioning were performed in 6, 3 and 6 cases, respectively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good general health

排除标准

  • systemic disorders; known hypersensitivity to any of the study medications; pregnancy or nursing; local contraindication to surgery as judged by the oral surgeon; and use of any analgesic agent 24 hours before surgery.

研究组 & 干预措施

Dipyrone

Experimental

Analgesic affectiveness using Dipyrone (500mg) as a postoperative drug for pain relief.

Intervention: "Drug: dipyrone and acetaminophen"

干预措施: dipyrone and acetaminophen (Drug)

Acetaminophen

Experimental

Analgesic affectiveness using Acetaminophen (750mg) as a postoperative drug for pain relief.

Intervention: "Drug: dipyrone and acetaminophen"

干预措施: dipyrone and acetaminophen (Drug)

结局指标

主要结局

Pain control with analgesics drugs

时间窗: forty-eight hours

次要结局

  • visual analog scale(forty-eight hours)

研究者

发起方
University Center of Araraquara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thallita Pereira Queiroz

Thallita Pereira Queiroz, DDS, MSc, PhD

University Center of Araraquara

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