Celecoxib in Colposcopic Directed Biopsy

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Colposcopy

Intervention / Treatment
-----------------
* Drug: Celecoxib 200mg
* Procedure: Colposcopic guided biopsy
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celecoxib group<br>will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy | Drug: Celecoxib 200mg<br>* oral capsule 3 hours before procedure<br>* Other names: celebrex 200;Procedure: Colposcopic guided biopsy<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy | Procedure: Colposcopic guided biopsy<br>* 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.<br>Drug: Placebo oral capsule<br>* oral capsule 3 hours before procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure | Visual analog score in mm on a 10 cm ruler | Immediately after the first biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at time of vaginal speculum application | Visual analog score in mm on a 10 cm ruler | At time of introduction of vaginal speculum | 
| Post-procedure pain | Visual analog score in mm on a 10 cm ruler | At 30 minutes after completing the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colposcopy - colposcopic directed biopsy - celecoxib