A Phase 3 interventional study of Tramadol and Diclofenac in Pain, Post Procedural and Pain, Procedural, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by Cairo University · Phase 3, Interventional, and Prevention
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 210 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Women will receive oral Tramadol 100 mg before the procedure
Drug: Tramadol
Women will receive oral diclofenac 100 mg before the procedure
Drug: Diclofenac
Women will receive oral placebo 1 hour before the procedure.
Drug: Placebo
Women will receive oral tramadol 100 mg 1 hour before the procedure
Women will receive 100 mg diclofenac 1 hour before the procedure
Women will receive a placebo 1 hour before the procedure
Pain during the procedure
Women will be asked to score their pain using a visual analogue scale
Time frame: 5 minutes after starting the procedure
Pain after the procedure
Women will be asked to score their pain using a visual analogue scale
Time frame: 30 minutes after competing the procedure
The record gives a start of Apr 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tramadol · Diclofenac