Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy: a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction of total mean pain index (as measured on a 10-point Likert scale)
研究概览
简要总结
Patients will be randomized to receive diclophenac sodium or placebo two hours before diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the primary outcome. Patients will be followed until hospital discharge, an average of 10 days.
详细描述
Aim:
To determine the effectiveness of oral diclophenac sodium on the quality of colonoscopy and pain control during diagnostic colonoscopy in hospitalized patients.
Hypothesis:
Null hypothesis: there is no statistically significant difference between diclophenac sodium and placebo on parameters of quality of colonoscopy and pain control in hospitalized patients undergoing diagnostic colonoscopy.
Outcomes:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •all inpatients that are referred for colonoscopy for any indication during their hospital stay.
排除标准
- •refusal to sign informed consent
- •age <18 years
- •pregnancy
- •lactation
- •allergy to any nonsteroidal antiinflammatory drug
- •patients that have taken any nonsteroidal antiinflammatory drug in the previous seven days before
- •randomisation (except acetylsalicylic acid in doses up to 300 mg/day)
- •patients on antiplatelet or anticoagulation therapy (except acetylsalicylic acid in doses up to 300 mg/day)
- •history of gastric or duodenal ulcer
- •history of GI bleeding or perforation
- •history of or active inflammatory bowel disease
- •severe liver disease (defined as presence of history of ascites and/or esophageal varices)
- •severe kidney disease (defined as glomerular filtration rate <30 ml/min)
- •history of myocardial infarction or cerebrovascular disease
- •history of peripheral arterial disease
- •congestive heart failure (NYHA III-IV)
- •history of systemic lupus erythematosus
研究组 & 干预措施
Diclophenac sodium 100mg p.o.
Patients will be given 100mg of diclophenac sodium two hours prior to colonoscopy.
干预措施: diclophenac sodium (Drug)
Placebo
Patients will be given placebo tablets of same appearance as the intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of total mean pain index (as measured on a 10-point Likert scale)
时间窗: Patients will be followed until hospital discharge, an average of 10 days.
次要结局
- Reduction of pain in the subgroup of patients with high pain index (defined as patients that report 7-10, inclusive, on a 10-point Likert scale)(Patients will be followed until hospital discharge, an average of 10 days.)
- Reduction of pain in the subgroup of patients with moderate pain index (defined as patients that report 3-6, inclusive, on a 10-point Likert scale)(Patients will be followed until hospital discharge, an average of 10 days.)
- Time to discharge(Patients will be followed until hospital discharge, an average of 10 days.)
- Proportion of patients that are willing to repeat the procedure, if necessary(Patients will be followed until hospital discharge, an average of 10 days.)
- Need for sedation or analgesia during colonoscopy(Patients will be followed until hospital discharge, an average of 10 days.)
研究者
Vanja Giljaca
Vanja Giljaca, MD, PhD
University Hospital Rijeka