Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Pain during the procedure
研究概览
简要总结
Women often experience pain and discomfort during colposcopic examination especially at time of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may also increase pain, woman's cooperation during the procedure is affected by all these factors, which also may hinder the colposcopist from obtaining adequate data and biopsies.
Several pharmacological and non-pharmacological methods have been studied to reduce pain associated colposcopic directed biopsy (CDB). We aim to study the effect of Celecoxib to reduce pain associated with CDB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18-65 years old who undergoing colposcopic directed biopsy
排除标准
- •A known allergy to Celecoxib, aspirin or another NSAID.
- •Active peptic ulceration or gastrointestinal bleeding.
- •Inflammatory bowel disease.
- •Congestive heart failure (NYHA II-IV).
- •Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
- •History of neurologic deficit.
- •Known hepatic or renal impairment.
- •Pregnancy.
- •Breast-feeding.
- •Post-hysterectomy.
- •Bleeding disorders.
- •Drug abuse.
- •Cervical and vaginal infection.
研究组 & 干预措施
Celecoxib group
will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
干预措施: Celecoxib 200mg (Drug)
Celecoxib group
will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
干预措施: Colposcopic guided biopsy (Procedure)
Placebo group
will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy
干预措施: Colposcopic guided biopsy (Procedure)
Placebo group
will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Pain during the procedure
时间窗: Immediately after the first biopsy
Visual analog score in mm on a 10 cm ruler
次要结局
- Post-procedure pain(At 30 minutes after completing the procedure)
- Pain at time of vaginal speculum application(At time of introduction of vaginal speculum)
研究者
Ahmed AA Wali, MD
Lecturer of Obstetrics and Gynecology
Cairo University