Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, Magnesium Therapy, Pain Management
Brief summary
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.
Detailed description
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.
Interventions
DRUGMagnesium Sulfate (2 Ampoules)
Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes.
DRUGDexketoprofen
Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.
Sponsors
Havva Betül Bacak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity measured by Visual Analog Scale (VAS) | Baseline and 1 hour after intravenous treatment | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactecenur çelikoğlu, md
Backup Contactyağmur acıyiyen, md
Outcome results
None listed