Overview

Tramadol Versus Celecoxib in Reducing Pain Associated With IUD Insertion

Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
0
Participant gender:
Female
Summary
Two hundred and ten women requesting IUD insertion will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used 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 in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. After insertion of the IUD the women's pain perception will be assessed using a visual analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10 corresponding to the worst possible pain.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
Treatments:
Celecoxib
Tramadol
Criteria
Inclusion Criteria:

- Women with expected difficult IUD insertion like nulliparous women and women with
previous cesarean section.

Exclusion Criteria:

- Previous vaginal delivery.

- Submucous myoma.

- Uterine anomalies.

- Undiagnosed vaginal bleeding.

- Pelvic inflammatory disease.