Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03585036
• Other study ID #: tramadol
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2018
• Est. completion date: October 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: AHMED SAMY, MD
• Phone: 01100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 dexketoprofen.

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

Drug:
• dexketoprofen
Drug: dexketoprofen Women will receive oral dexketoprofen 25mg 2 hours before the procedure Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.
• Tramadol
Drug: Tramadol Women will receive oral Tramadol 100 mg 2 hours before the procedure Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure
• Placebo
Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure. Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's perception of pain during the procedure	The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain	2 minutes after starting the procedure
Secondary	Pain after the procedure	The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain.	30 minutes after completing the procedure