Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

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

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.

Study Overview

• Status: Unknown
• Conditions: Hysteroscopy
• Intervention / Treatment: Drug: dexketoprofen; Drug: Tramadol; Drug: Placebo

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AHMED SAMY, MD; Phone Number: 01100681167; Email: ahmedsamy8233@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
ACTIVE_COMPARATOR: 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 .	Drug: 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_COMPARATOR: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: AHMED SAMY, MD, lecturer in obstetrics and gynecology,cairo university

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Analgesics, Opioid; Narcotics; Tramadol; Dexketoprofen trometamol
• Other Study ID Numbers: tramadol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No