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

NCT02736019 | Unknown Phase 3 DMC

• 1 other identifier: Hyst 7
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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 Celecoxib 200mg (Celebrex® 200, Pfizer, USA) 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. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

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.

  2 minutes after starting the procedure

Secondary Outcomes (1)

• Pain after the procedure

  30 minutes after completing the procedure

Study Arms (3)

Celecoxib

ACTIVE COMPARATOR

Women will receive oral celecoxib 200mg 2 hours before the procedure

Drug: Celecoxib; Drug: Placebo 1

Tramadol

ACTIVE COMPARATOR

Women will receive oral Tramadol 100mg 2 hours before the procedure

Drug: Tramadol; Drug: Placebo 2

Placebo

PLACEBO COMPARATOR

Women will receive a placebo similar to celecoxib and a placebo similar to Tramadol

Drug: Placebo 1; Drug: Placebo 2

Interventions

Celecoxib DRUG

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Celecoxib

Tramadol DRUG

Women will receive oral Tramadol 100 mg 2 hours before the procedure

Tramadol

Placebo 1 DRUG

Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Celecoxib; Placebo

Placebo 2 DRUG

Women will receive an oral placebo similar to celecoxib 2 hours before the procedure

Placebo; Tramadol

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 Celecoxib.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

• Hassan A, Wahba A, Haggag H. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Hum Reprod. 2016 Jan;31(1):60-6. doi: 10.1093/humrep/dev291. Epub 2015 Nov 29.

  PMID: 26621854 BACKGROUND

• Ahmad G, Attarbashi S, O'Flynn H, Watson AJ. Pain relief in office gynaecology: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):3-13. doi: 10.1016/j.ejogrb.2010.11.018. Epub 2011 Jan 20.

  PMID: 21255900 BACKGROUND

• van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.

  PMID: 17516956 BACKGROUND

MeSH Terms

Interventions

Celecoxib; Tramadol

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• AbdelGany M Hassan

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdelGany M Hassan, MRCOG, MD

CONTACT

+201017801604; abdelgany2@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 of Gynecology and Obstetrics

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 13, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Last Updated: July 6, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)