Celecoxib in Colposcopic Directed Biopsy

Colposcopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464552
• Other study ID #: N-2aa6-2018
• Status: Completed
• Phase: Phase 4
• Start date: April 15, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colposcopy

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of pain score on duration of the colposcopic procure	Duration in minutes (from introduction of vaginal speculum till its removal)	At time of removal of vaginal speculum
Primary	Pain during the procedure	Visual analog score in mm on a 10 cm ruler	Immediately after the first biopsy
Secondary	Pain at time of vaginal speculum application	Visual analog score in mm on a 10 cm ruler	At time of introduction of vaginal speculum
Secondary	Post-procedure pain	Visual analog score in mm on a 10 cm ruler	At 30 minutes after completing the procedure