Tramadol Versus Celecoxib for Reducing Pain in Outpatient Hysteroscopy
|ClinicalTrials.gov Identifier: NCT02071303|
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Tramadol Drug: Celecoxib Drug: Placebo||Phase 2|
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.
Several drugs have been used to reduce pain during the procedure. Celecoxib is a highly selective Cyclooxygenase-2 inhibitor (COX-2 inhibitor) whereas other Non-steroidal anti-inflammatory drugs (NSAIDS) like Ibuprofen, Diclofenac, and Naproxen inhibit both COX-1 and COX-2. COX-1 is the only isoenzyme found in platelets, and plays a role in the protection of the gastrointestinal mucosa, renal hemodynamics, and platelet thrombogenesis. In theory, this selectivity allows celecoxib and other COX-2 inhibitors to reduce inflammation and pain while minimizing gastrointestinal adverse drug reactions. COX-1 is involved in synthesis of prostaglandins and thromboxane, but COX-2 is only involved in the synthesis of prostaglandin. Therefore, inhibition of COX-2 inhibits only prostaglandin synthesis without affecting thromboxane, so offers no cardioprotective effects of nonselective NSAIDs .
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.
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, celecoxib 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 Celecoxib 200mg (Celebrex® 200, Pfizer) 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)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Tramadol Versus Celecoxib for Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Tramadol
Women will receive Tramadol 100mg 1 hour before the procedure.
Tramadol 100mg will be given to 70 women before the procedure.
Active Comparator: Celecoxib
Women will receive Celecoxib 200mg 1 hour before the procedure.
Celecoxib 200mg will be given to 70 women before the procedure.
Placebo Comparator: Placebo
Women will receive a placebo 1 hour before the procedure.
A placebo will be given to 70 women before the procedure.
- Pain perception during the procedure [ Time Frame: 10 minutes after starting the procedure. ]Pain will be assessed using a visual analogue scale 10 minutes after inserting the hysteroscope.
- Pain perception after the procedure [ Time Frame: 30 minutes after the procedure. ]Pain will be assessed using a visual analogue scale 30 minutes after the procedure.
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): NCT02071303
|Cairo University Hospitals|
|Principal Investigator:||AbdelGany MA Hassan, MRCOG, MD||Cairo University|