Pain Clinical Trial
Official title:
Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women: A Randomized Double Blind Placebo Controlled Trial
NCT number | NCT02425709 |
Other study ID # | Hyst 4 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | April 21, 2015 |
Last updated | January 20, 2017 |
Start date | April 2015 |
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Post menopausal women. - Indication for outpatient hysteroscopy Exclusion Criteria: - Allergy to tramadol or diclofenac - Cardiac renal or gastric disease. - Diabetes or hypertension |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo university hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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