Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02339428
• Date of registration: 07/01/2015
• Prospective Registration: No
• Primary sponsor: University Hospital Rijeka
• Public title: Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy
• Scientific title: Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy: a Randomized Controlled Study
• Date of first enrolment: January 2015
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02339428
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Croatia

Contacts

• Name: Vanja Giljaca, MD, PhD
• Affiliation: University Hospital Center Rijeka

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

Drug: Placebo

Drug: diclophenac sodium

Primary Outcome(s)

Reduction of total mean pain index (as measured on a 10-point Likert scale) [Time Frame: Patients will be followed until hospital discharge, an average of 10 days.]

Secondary Outcome(s)

Proportion of patients that are willing to repeat the procedure, if necessary [Time Frame: Patients will be followed until hospital discharge, an average of 10 days.]

Time to discharge [Time Frame: Patients will be followed until hospital discharge, an average of 10 days.]

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) [Time Frame: Patients will be followed until hospital discharge, an average of 10 days.]

Need for sedation or analgesia during colonoscopy [Time Frame: 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) [Time Frame: Patients will be followed until hospital discharge, an average of 10 days.]

Secondary ID(s)

UHRijeka-diclo-colono

Source(s) of Monetary Support

Please refer to primary and secondary sponsors