Clinical Trials Logo

Clinical Trial 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 dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) 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.


Clinical Trial Description

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 dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) 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.

Statistics:

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03585036
Study type Interventional
Source Cairo University
Contact AHMED SAMY, MD
Phone 01100681167
Email ahmedsamy8233@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date July 2018
Completion date October 2018

See also
  Status Clinical Trial Phase
Completed NCT05514236 - Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy N/A
Completed NCT06092541 - Pericervical Analgesia Versus Analesia With Nitrous Oxide (N2O) in Outpatien Operative Hysteroscopy With Miniresector N/A
Not yet recruiting NCT05069077 - the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women N/A
Completed NCT03701984 - The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy Phase 4
Not yet recruiting NCT05069025 - Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients N/A
Completed NCT04166500 - Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion N/A
Not yet recruiting NCT06379841 - Green Hysteroscopy N/A
Completed NCT02863679 - Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel N/A
Completed NCT02142686 - Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy N/A
Completed NCT02142673 - The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain. N/A
Completed NCT05540379 - Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence N/A
Completed NCT04462835 - Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy
Recruiting NCT04862598 - Virtual Reality to Improve Satisfaction in Hysteroscopy Patients N/A
Recruiting NCT01376934 - Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques N/A
Not yet recruiting NCT06172140 - Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy N/A
Recruiting NCT03409835 - Effect of Ramosetron on Post-discharge Nausea and Vomiting N/A
Enrolling by invitation NCT03579550 - Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus N/A
Recruiting NCT02736019 - Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women Phase 3
Recruiting NCT02736071 - Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy Phase 3
Not yet recruiting NCT05858931 - Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects