Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy
|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: NCT02419651|
Recruitment Status : Unknown
Verified January 2017 by AbdelGany Hassan, Cairo University.
Recruitment status was: Recruiting
First Posted : April 17, 2015
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Post Procedural Pain, Procedural||Drug: Tramadol Drug: Diclofenac Drug: Placebo||Phase 3|
Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. 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 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 oral consent. Written informed consent is not needed since the procedure and intervention carries almost no risk to the patient and the patient will not receive anesthesia and will be fully conscious. Only patients consenting verbally to participate will be included in the trial.
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 who will receive Tramadol 100mg (Trama SR®, Global Napi) orally 1 hour before the procedure, group II who will receive diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who 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. The anterior wall, posterior wall and tubal ostea will be visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Base line characteristics and perception of pain will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Tramadol Versus Diclofenac for Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Tramadol
Women will receive oral Tramadol 100 mg before the procedure
Women will receive oral tramadol 100 mg 1 hour before the procedure
Active Comparator: Diclofenac
Women will receive oral diclofenac 100 mg before the procedure
Women will receive 100 mg diclofenac 1 hour before the procedure
Placebo Comparator: Placebo
Women will receive oral placebo 1 hour before the procedure.
Women will receive a placebo 1 hour before the procedure
- Pain during the procedure [ Time Frame: 5 minutes after starting the procedure ]Women will be asked to score their pain using a visual analogue scale
- Pain after the procedure [ Time Frame: 30 minutes after competing the procedure ]Women will be asked to score their pain using a visual analogue scale
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): NCT02419651
|Cairo University Hospitals||Recruiting|
|Contact: AbdelGany MA Hassan, MRCOG, MD 00217801604 firstname.lastname@example.org|
|Principal Investigator: AbdelGany MA Hassan, MRCOG, MD|