Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy
1 other identifier
interventional
210
1 country
2
Brief Summary
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 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 P50-P75 for phase_3 pain
Started Apr 2015
Longer than P75 for phase_3 pain
2 active sites
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 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 8, 2019
April 1, 2019
4.7 years
April 24, 2015
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain during the procedure as measured by the visual analogue scale
Women will be asked to score their pain using a visual analogue scale
5 minutes after starting the procedure
Pain after the procedure as measured by the visual analogue scale
Women will be asked to score their pain using a visual analogue scale
30 minutes after completing the procedure
Study Arms (3)
Tramadol
ACTIVE COMPARATORWomen will receive oral tramadol 100 mg 1 hour before the procedure
Diclofenac
ACTIVE COMPARATORWomen will receive oral diclofenac 100 mg 1 hour before the procedure
Placebo
PLACEBO COMPARATORWomen will receive an oral placebo 1 hour before the procedure
Interventions
Eligibility Criteria
You may qualify if:
- Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.
You may not qualify if:
- Known allergy to tramadol or diclofenac.
- Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
BeniSuef University hospitals
BeniSuef, Egypt
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 24, 2015
First Posted
April 29, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 8, 2019
Record last verified: 2019-04