Clinical trial NCT02425709: Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
Official title: Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women: A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hysteroscopy
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 210
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Pain during the procedure measured using a visual analogue scale
timeFrame: 5 minutes after starting the procedure
measure: Pain immediately after the procedure measured using a visual analogue scale
timeFrame: 1 minute after completing the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
References:
citation: 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.
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. doi: 10.1111/j.1471-0528.2007.01326.x.