Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women

NCT ID: NCT02425709

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Hysteroscopy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Diclofenac

women will receive oral diclofenac 50 mg 1 hour before the procedure.

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

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

Tramadol

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

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

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

Placebo

Women will receive a placebo 1 hour before the procedure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Women will receive an oral placebo 1 hour before the procedure

Interventions

Diclofenac

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

Intervention Type: DRUG

Tramadol

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

Intervention Type: DRUG

Placebo

Women will receive an oral placebo 1 hour before the procedure

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

AbdelGany M Hassan, MRCOG, MD

Role: CONTACT

abdelgany2@gmail.com

+201017801604

Facility Contacts

AbdelGany Hassan, MRCOG, MD

Role: primary

abdelgany2@gmail.com

002 01017801604

References

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.

Reference Type: BACKGROUND

PMID: 21255900 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17516956 (View on PubMed)

Other Identifiers

Hyst 4

Identifier Type: -

Identifier Source: org_study_id