Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy
NCT ID: NCT02068209
Last Updated: 2015-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2014-05-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
NCT02425709
Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy
NCT02419651
Tramadol Versus Celecoxib for Reducing Pain in Outpatient Hysteroscopy
NCT02071303
Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy
NCT02428777
Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy
NCT02736071
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide written consents. Only patients consenting to participate will be included in the trial.
Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.
Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg. The anterior wall, posterior wall and tubal ostea will be visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tramadol
Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy
Tramadol
patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
Placebo
Patients will receive a placebo 1 hour before the procedure.
Placebo
patients will receive a placebo 1 hour before outpatient hysteroscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tramadol
patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
Placebo
patients will receive a placebo 1 hour before outpatient hysteroscopy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent to the procedure
Exclusion Criteria
* Known cardiac disease
* Known allergy to Tramadol
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AbdelGany Hassan
Dr Hassan
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AbdelGany MA Hassan, MRCOG, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University Hospitals
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Floris S, Piras B, Orru M, Silvetti E, Tusconi A, Melis F, Tuveri M, Piga M, Paoletti AM, Melis GB. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertil Steril. 2007 Jan;87(1):147-51. doi: 10.1016/j.fertnstert.2006.05.072. Epub 2006 Nov 1.
Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.
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.
O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.
Modi H, Mazumdar B, Bhatt J. Study of interaction of tramadol with amlodipine in mice. Indian J Pharmacol. 2013 Jan-Feb;45(1):76-9. doi: 10.4103/0253-7613.106440.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Gany-123
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.