IV Magnesium in the Treatment of Acute Dysmenorrhea (IVMAG)

Evaluation of Intravenous Magnesium Administration in the Treatment of Dysmenorrhea

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.

Study Overview

• Status: Recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: Magnesium Sulfate (2 Ampoules); Drug: Dexketoprofen

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ecenur çelikoğlu, md; Phone Number: +90 538 54 92 848; Email: ecenurcelikoglu14@gmail.com
• Study Contact Backup: Name: yağmur acıyiyen, md; Phone Number: +905425669593; Email: yagmuraciyiyen95@gmail.com

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Gaziosmanpaşa, Outside of the US, Turkey (Türkiye), 33400
      • Recruiting
      • SBÜ Gaziosmanpaşa Training and Research Hospital
      • Contact: ecenur çelikoğlu, md; Phone Number: +90 538 54 92 848; Email: ecenurcelikoglu14@gmail.com
      • Contact: yağmur acıyiyen, md; Phone Number: +9005425669593; Email: yagmuraciyiyen95@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Intravenous Dexketoprofen; Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes.	Drug: Dexketoprofen; Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Havva Betül Bacak
• Investigators: Principal Investigator: havva betül bacak, md, SBÜ Gaziosmanpaşa Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Pain Management; Magnesium Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Neurobehavioral Manifestations; Pelvic Pain; Perceptual Disorders; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Dysmenorrhea; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate; dexketoprofen trometamol
• Other Study ID Numbers: GOP-IVMAG-DYSMENORRHEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No