跳至主要内容
临床试验/2022-500377-13-01
2022-500377-13-01招募中4 期

Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa10 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年5月27日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
300
试验地点
10
主要终点
This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

研究概览

简要总结

To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.

入排标准

年龄范围
18 years 至 65+ years(65+ Years, 18-64 Years)
接受健康志愿者

入选标准

  • Men or women over 18 years of age.
  • Patients scheduled for outpatient surgical extraction, under local anesthesia, of at least two impacted third molars, at least one of which will require bone removal.
  • Patients who agree to participate in the study and give written consent.

排除标准

  • Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen.
  • Patients on treatment with bisphosphonates.
  • Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit.
  • Patients suffering from other uncontrolled diseases.
  • Pregnant or breastfeeding women.
  • Patients with contraindications for treatment with tramadol or dexketoprofen.

结局指标

主要结局

This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

次要结局

未报告次要终点

研究者

申办方类型
Laboratory/Research/Testing facility
责任方
Principal Investigator
主要研究者

Fundacion Para La Investigacion Biomedica

Scientific

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

研究点 (10)

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