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The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU].
Patients fulfilling inclusion and exclusion criteria will be divided into three groups.
Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.
Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.
Group C (control group) Include 34 patients who will receive a placebo.
Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol | Active Comparator | Women will receive oral tramadol 100 mg 1 hour before the procedure |
|
| Diclofenac | Active Comparator | Women will receive 100 mg diclofenac 1 hour before the procedure |
|
| Placebo | Placebo Comparator | Women will receive a placebo 1 hour before the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Women will receive a oral Tramadol 100mg 1 hour before the procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during the procedure | Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy | intraoperative |
| pain after the procedure | 15 minutes after procedure using a 100mm line visual analog scale | 15 minutes after completing the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect and difficulties | Recorded in Case Record Form | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Elsayed Elbohoty, MD | Contact | elbohoty79@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Diclofenac |
| Drug |
Women will receive oral Diclofenac 100mg 1 hour before the procedure |
|
| Placebo | Drug | Women will receive a Placebo 1 hour before the procedure |
|
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |