Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-01
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Magnesium Sulfate 2 Ampoules
Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes.
Magnesium Sulfate (2 Ampoules)
Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes.
Intravenous Dexketoprofen
Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes.
Dexketoprofen
Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.
Interventions
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Magnesium Sulfate (2 Ampoules)
Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes.
Dexketoprofen
Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
35 Years
FEMALE
No
Sponsors
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Havva Betül Bacak
OTHER_GOV
Responsible Party
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Havva Betül Bacak
md
Principal Investigators
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havva betül bacak, md
Role: PRINCIPAL_INVESTIGATOR
SBÜ Gaziosmanpaşa Training and Research Hospital
Locations
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SBÜ Gaziosmanpaşa Training and Research Hospital
Gaziosmanpaşa, Outside of the US, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GOP-IVMAG-DYSMENORRHEA
Identifier Type: -
Identifier Source: org_study_id
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