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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03464552

Enrollment

170

Registered

2018-03-14

Start date

2018-04-15

Completion date

2019-06-30

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colposcopy

Keywords

colposcopy - colposcopic directed biopsy - celecoxib

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.

Interventions

DRUGCelecoxib 200mg

oral capsule 3 hours before procedure

PROCEDUREColposcopic 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.

DRUGPlacebo oral capsule

oral capsule 3 hours before procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Effect of pain score on duration of the colposcopic procure	At time of removal of vaginal speculum	Duration in minutes (from introduction of vaginal speculum till its removal)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026