Colposcopy Clinical Trial
Official title:
Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
Verified date | October 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: • Females 18-65 years old who undergoing colposcopic directed biopsy Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of pain score on duration of the colposcopic procure | Duration in minutes (from introduction of vaginal speculum till its removal) | At time of removal of vaginal speculum | |
Primary | Pain during the procedure | Visual analog score in mm on a 10 cm ruler | Immediately after the first biopsy | |
Secondary | Pain at time of vaginal speculum application | Visual analog score in mm on a 10 cm ruler | At time of introduction of vaginal speculum | |
Secondary | Post-procedure pain | Visual analog score in mm on a 10 cm ruler | At 30 minutes after completing the procedure |
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