Overview

Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
Celecoxib
Tramadol
Criteria
Inclusion Criteria:

- Post menopausal women.

- vaginal bleeding.

- Endometrial thickness >4mm.

Exclusion Criteria:

- Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal , liver
disease.

- Gastritis or peptic ulcer.

- Allergy to Tramadol or Celecoxib.