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This prospective, randomized, double-blind clinical trial aims to evaluate the analgesic efficacy of intravenous magnesium sulfate in women presenting to the emergency department with acute dysmenorrhea. Participants will be randomized into two groups receiving either 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Pain levels will be assessed using the Visual Analog Scale (VAS) before and after treatment.
This prospective, randomized, double-blind clinical trial is designed to evaluate the analgesic effectiveness of intravenous magnesium sulfate in women aged 18 to 35 years presenting to the emergency department with acute dysmenorrhea. Participants will be randomly assigned to one of two treatment groups: 2 ampoules of magnesium sulfate or intravenous dexketoprofen.
All medications will be diluted in 100 ml of normal saline and administered intravenously over 15 minutes. Pain intensity will be assessed using the Visual Analog Scale (VAS) before treatment and 1 hour after administration. Secondary outcomes include patient satisfaction, vital sign changes, and adverse effects.
The study aims to compare the analgesic efficacy and safety profile of intravenous magnesium sulfate with that of a standard nonsteroidal anti-inflammatory drug (dexketoprofen) in the management of acute dysmenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate 2 Ampoules | Experimental | Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes. |
|
| Intravenous Dexketoprofen | Active Comparator | Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate (2 Ampoules) | Drug | Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity measured by Visual Analog Scale (VAS) | Pain severity will be assessed using the 0-10 Visual Analog Scale (VAS) before treatment and 1 hour post-treatment. The study will evaluate and compare the analgesic effect of two different doses of intravenous magnesium sulfate (2 ampoules vs. 3 ampoules) and compare both to intravenous dexketoprofen in women presenting with acute dysmenorrhea. | Baseline and 1 hour after intravenous treatment |
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Inclusion Criteria:
Female patients aged 18 to 35 years
Presenting to the obstetrics and gynecology emergency department with a diagnosis of primary dysmenorrhea
Having regular menstrual cycles within the last 6 months
Having a Visual Analog Scale (VAS) pain score of ≥6 at emergency admission
Providing written informed consent for participation in the study
Exclusion Criteria:
Patients with secondary dysmenorrhea or underlying gynecological pathology
Pregnancy or breastfeeding
Use of analgesics or muscle relaxants within the last 3 days
Known allergy to magnesium sulfate or dexketoprofen trometamol
History of renal failure, cardiac arrhythmia, or serious systemic disease
Inability to assess pain due to mental disability or communication disorder
Failure to provide informed consent for participation in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ecenur çelikoğlu, md | Contact | +90 538 54 92 848 | ecenurcelikoglu14@gmail.com | |
| yağmur acıyiyen, md | Contact | +905425669593 | yagmuraciyiyen95@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| havva betül bacak, md | SBÜ Gaziosmanpaşa Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Gaziosmanpaşa Training and Research Hospital | Recruiting | Gaziosmanpaşa | Outside of the US | 33400 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| C118296 | dexketoprofen trometamol |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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This is a prospective, randomized, double-blind, parallel assignment clinical trial where participants are allocated into two groups to receive different intravenous treatments: 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Each treatment is administered over 15 minutes, and pain outcomes are compared between groups.
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| Dexketoprofen | Drug | Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes. |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |