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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03464552
Other study ID # N-2aa6-2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 15, 2018
Est. completion date June 30, 2019

Study information

Verified date October 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Celecoxib 200mg
oral capsule 3 hours before procedure
Procedure:
Colposcopic guided biopsy
Patient is placed in the lithotomy position. Vulva is examined for any suspicious lesions. A sterile bivalve speculum is introduced into the vagina to inspect cervix. A 3% acetic acid solution is applied to the cervix to map acetowhite areas for colposcopic directed punch biopsy using Tischler punch forceps.
Drug:
Placebo oral capsule
oral capsule 3 hours before procedure

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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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