Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hysteroscopy; Pain
Intervention: Diclofenac (Drug); Tramadol (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Cairo University Overall contact: AbdelGany M Hassan, MRCOG, MD, Phone: +201017801604, Email: abdelgany2@gmail.com
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.
Clinical Details
Official title: Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women: A Randomized Double Blind Placebo Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Pain during the procedure measured using a visual analogue scalePain immediately after the procedure measured using 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.
Eligibility
Minimum age: 50 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Post menopausal women.
- Indication for outpatient hysteroscopy
Exclusion Criteria:
- Allergy to tramadol or diclofenac
- Cardiac renal or gastric disease.
- Diabetes or hypertension
Locations and Contacts
AbdelGany M Hassan, MRCOG, MD, Phone: +201017801604, Email: abdelgany2@gmail.com
Cairo university hospitals, Cairo, Egypt; Recruiting AbdelGany Hassan, MRCOG, MD, Phone: 002 01017801604, Email: abdelgany2@gmail.com AbdelGany MA Hassan, MRCOG, MD, Principal Investigator Mohamed MM Kotb, MD, Sub-Investigator
Additional Information
Related 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. Review. 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.
Starting date: April 2015
Last updated: April 24, 2015
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