Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02425709
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

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.

Condition or disease Intervention/treatment Phase
Hysteroscopy Pain Drug: Diclofenac Drug: Tramadol Drug: Placebo Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women: A Randomized Double Blind Placebo Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Diclofenac
women will receive oral diclofenac 50 mg 1 hour before the procedure.
Drug: Diclofenac
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.
Drug: Tramadol
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.
Drug: Placebo
Women will receive an oral placebo 1 hour before the procedure




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425709


Contacts
Layout table for location contacts
Contact: AbdelGany M Hassan, MRCOG, MD +201017801604 abdelgany2@gmail.com

Locations
Layout table for location information
Egypt
Cairo university hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany Hassan, MRCOG, MD    002 01017801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sub-Investigator: Mohamed MM Kotb, MD         
Sponsors and Collaborators
Cairo University

Publications:
Layout table for additonal information
Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02425709     History of Changes
Other Study ID Numbers: Hyst 4
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants