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OpenTrials
Completed

NCT Number: NCT03464552

Celecoxib in Colposcopic Directed Biopsy

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.

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Key information

Conditions

Colposcopy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib 200mg

Drug

oral capsule 3 hours before procedure

Other names: celebrex 200

Colposcopic guided biopsy

Procedure

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.

Placebo oral capsule

Drug

oral capsule 3 hours before procedure

Primary outcomes

  1. Pain during the procedure

    Time frame: Immediately after the first biopsy

    Visual analog score in mm on a 10 cm ruler

Secondary outcomes

  1. Pain at time of vaginal speculum application

    Time frame: At time of introduction of vaginal speculum

    Visual analog score in mm on a 10 cm ruler

  2. Post-procedure pain

    Time frame: At 30 minutes after completing the procedure

    Visual analog score in mm on a 10 cm ruler

Other outcomes

  1. Effect of pain score on duration of the colposcopic procure

    Time frame: At time of removal of vaginal speculum

    Duration in minutes (from introduction of vaginal speculum till its removal)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2018
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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