Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain evolution, hours and days after surgery
研究概览
简要总结
Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.
The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy
详细描述
Objective
Evaluate the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy.
Material and methods
Controlled clinical trial, composed of 44 patients in a randomized manner, realized at the Coloproctology, Western Medical Center, Mexican Institute of Social Security. Referred beneficiaries adults were included, of either sex, who merited elective hemorrhoidectomy for hemorrhoidal disease grades III-IV using Ferguson's technique. They were assigned to receive metronidazole (study group) or homologated (control group) and the randomization was conducted by sealed envelopes and subsequently. We collected demographic and clinical variables. Postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days; additional analgesic use; complications; return to normal activity and patient satisfaction; also were measured, in a blood sample after surgery and 12 hrs later, interleukin 6 and 10.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemorrhoidal disease grade III and IV
- •Informed consent
排除标准
- •Pregnancy
- •Lactation
- •Other anorectal disease
- •Previous anorectal
- •hypersensibility to metronidazole
研究组 & 干预措施
Metronidazole
22 patients received oral metronidazole 500mg 3 times for day for 7 days
干预措施: Metronidazole (Drug)
Placebo
22 patients received oral placebo 500mg 3 times for day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Pain evolution, hours and days after surgery
时间窗: 6 and 12 hours, 1, 4, 7 and 14 days
Pain was assessed with the visual analogue scale questionnaire
次要结局
- Interleukin(after surgery and 12 hours)
- Analgesics(6 and 12 hours, 1, 4, 7 and 14 days)
- Surgery complications(6 and 12 hours, 1, 4, 7 and 14 days)
- Return to normal activities(1, 4, 7 and 14 days)
- Satisfaction(14 day)
研究者
CLOTILDE FUENTES OROZCO
PhD
Instituto Mexicano del Seguro Social