Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Rijeka
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• all inpatients that are referred for colonoscopy for any indication during their hospital stay.

Exclusion Criteria:

• 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