NCT03464552

Celecoxib in Colposcopic Directed Biopsy

Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colposcopy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-04-15
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-03-14
• Last updated: 2020-10-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study