Celecoxib in Colposcopic Directed Biopsy

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Colposcopy

Treatments: Drug: Celecoxib 200mg; Procedure: Colposcopic guided biopsy; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03464552

N-2aa6-2018

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups, including a placebo group

Celecoxib group

Active Comparator group

Description:

will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy

Treatment:

Procedure: Colposcopic guided biopsy

Drug: Celecoxib 200mg

Placebo group

Placebo Comparator group

Description:

will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy

Treatment:

Procedure: Colposcopic guided biopsy

Drug: Placebo oral capsule