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Recruiting NCT07248540

IV Magnesium in the Treatment of Acute Dysmenorrhea

No phase Interventional Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium Sulfate (2 Ampoules), Dexketoprofen.
Who it may be relevant to
Registry conditions: Dysmenorrhea. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Intravenous Magnesium Administration in the Treatment of Dysmenorrhea

Overview

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

  • Drug 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.
  • Drug Dexketoprofen
    Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.

Primary outcome measures

  • Change in pain intensity measured by Visual Analog Scale (VAS) [Time frame: Baseline and 1 hour after intravenous treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • SBÜ Gaziosmanpaşa Training and Research Hospital — Gaziosmanpaşa

Identifiers

NCT: NCT07248540 · GOP-IVMAG-DYSMENORRHEA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗