Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
1 other identifier
interventional
210
1 country
1
Brief Summary
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy in postmenopausal women. Postmenopausal women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 50 mg 1 hour before the procedure, the second group will receive diclofenac 50mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedJanuary 23, 2017
January 1, 2017
2.7 years
April 21, 2015
January 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Pain during the procedure measured using a visual analogue scale
Women will be asked to score their pain using a visual analogue scale
5 minutes after starting the procedure
Pain immediately after the procedure measured using a visual analogue scale
Women will be asked to score their pain using a visual analogue scale
1 minute after completing the procedure
Study Arms (3)
Diclofenac
ACTIVE COMPARATORwomen will receive oral diclofenac 50 mg 1 hour before the procedure.
Tramadol
ACTIVE COMPARATORWomen will receive oral tramadol 50 mg 1 hour before the procedure.
Placebo
PLACEBO COMPARATORWomen will receive a placebo 1 hour before the procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Post menopausal women.
- Indication for outpatient hysteroscopy
You may not qualify if:
- Allergy to tramadol or diclofenac
- Cardiac renal or gastric disease.
- Diabetes or hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university hospitals
Cairo, Egypt
Related Publications (2)
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: 21255900BACKGROUNDvan 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: 17516956BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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 21, 2015
First Posted
April 24, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2017
Last Updated
January 23, 2017
Record last verified: 2017-01