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临床试验/NCT02380001
NCT02380001已完成4 期

Analgesic Efficacy of Preoperative Oral Administration of Dexketoprofen Trometamol in Third Molar Surgery, Compared to Postoperative Administration

Daniel Chavarría Bolaños1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS).

研究概览

简要总结

The purpose of the present investigation is to evaluate the effectiveness of the preoperative administration of Dexketoprofen Trometamol, employing the third molar surgery model, when compared to postoperative administration of the same drug. It was hypothesized that preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8 hours of the surgery, when compared with post-operative administration.

详细描述

MODEL OF SURGICAL REMOVAL OF TOOTH IMPACTION. The model of Dental Impaction Pain Model (DIPM) is the most utilized of all the acute pain models. Its popularity is due to a well-established, well-validated, and extensively used postsurgery pain model in assessing the efficacy of analgesics on inflammatory pain.

The surgical procedure is very standardized and surgery require either minimal or nothing use of CNS depressant anesthetics. The methodology is similar to other models of acute pain; however, the DIPM is much more versatile than most other models. The model can be easily adapted to carry out studies of multiple-dose, pharmacokinetics / pharmacodynamics, preventive interventions and analgesic efficacy

The impacted lower third molar extraction involves the manipulation of hard and soft tissue, making the patient undergoes a series of effects which include acute pain, inflammation and trismus in the immediate postoperative period and goes from 24 to 72 postoperative hours. The pain associated with the surgical removal of a third molar is moderate to severe, increasing with greater intensity during the first 24 hours after surgery with spikes of pain between the first six to eight hours when using a conventional local anesthetic.

In this context, the control of pain and inflammation post-surgical associated with third molar removal has been very varied; highlighting the use of anti-inflammatory pain relievers non (NSAIDs) and some opioids.

PAIN. Pain is defined as the perception of a potentially injurious stimulus; which jointly to several not pleasurable experiences (sensory, emotional and cognitive), same that are caused by tissue damage (actual, potential or described in terms of such damage) and manifested by certain reactions physiological, autonomic and behavioral. Pain is typically classified as either acute or chronic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers between 18-28 years old
  • Clinical and radiographic diagnosis of impacted mandibular third molars, which the surgical approach may include flap and osteotomy procedures.
  • surgery classified as simple to moderate
  • Voluntary acceptance of written consent, previously approved by institutional ethics committee

排除标准

  • Prior administration of analgesic or anti-inflammatory drugs
  • History of drug dependence
  • History of allergic reactions to any of the drugs selected, or local anesthetics
  • Simultaneous presence of oral pathologies that may interfere with the surgical procedure

研究组 & 干预措施

Dexketoprofen trometamol

Experimental

A White round pill with 25 mg of dexketoprofen will be administered 30 minutes before the impacted third molar surgery start. Immediately after the surgery, a hard-gelatin capsule with placebo will be administered.

干预措施: Dexketoprofen trometamol (Drug)

Preoperative control

Placebo Comparator

A hard-gelatin capsule with placebo will be administered 30 minutes before the impacted third molar surgery start. Immediately after the surgery, a hard-gelatin capsule with 25mg of Dexketoprofen will be administered.

干预措施: Preoperative control (Drug)

结局指标

主要结局

Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS).

时间窗: 72 hours

Postoperative pain measurement will be held every 8 hours for the next 72 hours after the surgical intervention

次要结局

  • needing of second dosage administration(72 hours)
  • Number of patients with adverse events, to determine tolerability of the drugs.(7 days)

研究者

发起方
Daniel Chavarría Bolaños
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Chavarría Bolaños

Dr. Daniel Chavarría Bolaños, MSc. PhD

Universidad Autonoma de San Luis Potosí

研究点 (1)

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