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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02425709
Enrollment
210
Registered
2015-04-24
Start date
2015-04-30
Completion date
Unknown
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy, Pain

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.

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.

Interventions

DRUGDiclofenac

Women will receive oral diclofenac 50 mg 1 hour before the procedure

DRUGTramadol

Women will receive oral tramadol 50 mg 1 hour before the procedure

DRUGPlacebo

Women will receive an oral placebo 1 hour before the procedure

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Post menopausal women. * Indication for outpatient hysteroscopy

Exclusion criteria

* Allergy to tramadol or diclofenac * Cardiac renal or gastric disease. * Diabetes or hypertension

Design outcomes

Primary

MeasureTime frameDescription
Pain during the procedure measured using a visual analogue scale5 minutes after starting the procedureWomen will be asked to score their pain using a visual analogue scale
Pain immediately after the procedure measured using a visual analogue scale1 minute after completing the procedureWomen will be asked to score their pain using a visual analogue scale

Countries

Egypt

Contacts

Primary ContactAbdelGany M Hassan, MRCOG, MD
abdelgany2@gmail.com+201017801604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026