EUCTR2014-003969-24-ES进行中(未招募)1 期
Randomized clinical trial to analysis of pain after administration intramuscular benzathine penicillin needle gauge and length greater local anesthetic or not, in the administration with a traditional intramuscular needle with or without local anesthetic in patients with syphilis. Dolben Study . - Dolben Study
Vicente Estrada Pérez0 个研究点目标入组 104 人开始时间: 2014年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Support diagnosis of syphilis by serology (syphilis IgG + / + VDRL / TPHA + RPR + with) in the presence or absence of symptoms or clinical signs.
- •Need for treatment with intramuscular penicillin 2400000 U.
- •Acceptance to participate in the study after signing the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Diagnosis of neurosyphilis associated with possible impairment of sensory perception of pain after administration of the drug.
- •Cognitive impairment who are unable or have difficulty understanding and evaluating the degree of pain on the visual analogue scale (VAS).
- •Background hipersensibililidad to beta-lactams.
- •Known hypersensitivity to lidocaine.
- •Confinement in prison.
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