Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.

Detailed Description
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This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office 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 written consents. Only patients consenting to participate will be included in the trial. Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a 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 will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.

Official Title
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Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.

Conditions
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Pain

Intervention / Treatment
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* Drug: Tramadol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for outpatient hysteroscopy Consent to the procedure Exclusion Criteria: Premenstrual patients Known cardiac disease Known allergy to Tramadol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br>Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy | Drug: Tramadol<br>* patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.<br>* Other names: Tramadol 50mg;|
| Placebo Comparator: Placebo<br>Patients will receive a placebo 1 hour before the procedure. | Drug: Placebo<br>* patients will receive a placebo 1 hour before outpatient hysteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perceived by the patient during the procedure | Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure. | 10 minutes after starting the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perceived by the patient 30 minutes after the procedure. | The level of pain will be assessed 30 minutes after the procedure by a visual analogue scale. | 30 minutes after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outpatient hysteroscopy, Tramadol