Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

NCT03585036 | Unknown Phase 3

• 1 other identifier: tramadol
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain after the procedure

  30 minutes after completing the procedure

Study Arms (3)

dexketoprofen

ACTIVE COMPARATOR

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.

Drug: dexketoprofen

tramadol

ACTIVE COMPARATOR

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 .

Drug: Tramadol

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

dexketoprofen DRUG

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.

dexketoprofen

Tramadol DRUG

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

tramadol

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post menopausal women.
• vaginal bleeding.
• Endometrial thickness \>4mm.

You may not qualify if:

• Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal, liver disease.
• Gastritis or peptic ulcer.
• Allergy to Tramadol or dexketoprofen.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

dexketoprofen trometamol; Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• AHMED SAMY, MD

  lecturer in obstetrics and gynecology,cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

01100681167; ahmedsamy8233@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: July 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-06