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

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.

Study Overview

• Status: Completed
• Conditions: Colposcopy
• Intervention / Treatment: Drug: Celecoxib 200mg; Procedure: Colposcopic guided biopsy; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: colposcopy - colposcopic directed biopsy - celecoxib
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: N-2aa6-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes