- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425709
Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women: A Randomized Double Blind Placebo Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.
Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.
Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.
Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.
The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All postmenopausal 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.
Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I will receive Tramadol 50mg (Tramal ®, Memphis,) orally 1 hour before the procedure, group II will receive diclofenac 50mg (voltaren®, Novartis) 1 hour before the procedure, and group III will receive 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: AbdelGany M Hassan, MRCOG, MD
- Phone Number: +201017801604
- Email: abdelgany2@gmail.com
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Cairo University Hospitals
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Sub-Investigator:
- Mohamed MM Kotb, MD
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Contact:
- AbdelGany Hassan, MRCOG, MD
- Phone Number: 002 01017801604
- Email: abdelgany2@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Post menopausal women.
- Indication for outpatient hysteroscopy
Exclusion Criteria:
- Allergy to tramadol or diclofenac
- Cardiac renal or gastric disease.
- Diabetes or hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diclofenac
women will receive oral diclofenac 50 mg 1 hour before the procedure.
|
Women will receive oral diclofenac 50 mg 1 hour before the procedure
|
Active Comparator: Tramadol
Women will receive oral tramadol 50 mg 1 hour before the procedure.
|
Women will receive oral tramadol 50 mg 1 hour before the procedure
|
Placebo Comparator: Placebo
Women will receive a placebo 1 hour before the procedure.
|
Women will receive an oral placebo 1 hour before the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during the procedure measured using a visual analogue scale
Time Frame: 5 minutes after starting the procedure
|
Women will be asked to score their pain using a visual analogue scale
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5 minutes after starting the procedure
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Pain immediately after the procedure measured using a visual analogue scale
Time Frame: 1 minute after completing the procedure
|
Women will be asked to score their pain using a visual analogue scale
|
1 minute after completing the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Diclofenac
- Tramadol
Other Study ID Numbers
- Hyst 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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