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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib group | Active Comparator | will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy |
|
| Placebo group | Placebo Comparator | will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 200mg | Drug | oral capsule 3 hours before procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during the procedure | Visual analog score in mm on a 10 cm ruler | Immediately after the first biopsy |
| 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 |
| 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 |
Inclusion Criteria:
• Females 18-65 years old who undergoing colposcopic directed biopsy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 11562 | Egypt |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 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 |
|
| At 30 minutes after completing the procedure |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |