Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 主要终点
- patient-described pain level
研究概览
简要总结
The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.
详细描述
.Colposcopy-directed cervical biopsy (CDB) is a procedure performed in women with abnormal Papanicolaou smear or abnormal human papillomavirus (HPV) testing whose cervical lesions are colposcopically identified. Generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.The degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (VAS). Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure.
排除标准
- •Patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers.
- •Cervical and vaginal infection
- •pregnant patients.
- •Patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids
- •Patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, People with uncontrolled epilepsy.
- •People under the influence of (intoxicated with) alcohol, sleeping tablets, tranquilisers, psychotropic drugs (those affecting mood or emotions) or other opioid painkillers, e.g. morphine, codeine.
研究组 & 干预措施
Group I (tramadol group)
Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
干预措施: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet (Drug)
Group II (placebo oral tablet group)
group II will receive a placebo one hour before the procedure.the Treatment and placebo will be identical in form and packaging, without any identifying label.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
patient-described pain level
时间窗: the overall pain at 30 min after the procedure (postprocedure pain score)
(postprocedure pain score) using the visual analogue scale score from 0-10.
次要结局
- duration of colposcopy procedure.(from speculum insertion to colposcopy removal at the end of procedure.)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology,faculty of medicine,Cairo university.
Cairo University