IV Magnesium in the Treatment of Acute Dysmenorrhea

NCT07248540 | Recruiting

• 1 other identifier: GOP-IVMAG-DYSMENORRHEA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Keywords

Dysmenorrhea; Magnesium Therapy; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Magnesium Sulfate (2 Ampoules)

Intravenous Dexketoprofen

ACTIVE COMPARATOR

Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes.

Drug: Dexketoprofen

Interventions

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.

Magnesium Sulfate 2 Ampoules

Dexketoprofen DRUG

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

Intravenous Dexketoprofen

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

SBÜ Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Outside of the US, 33400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Agnosia

Interventions

Magnesium Sulfate; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• havva betül bacak, md

  SBÜ Gaziosmanpaşa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ecenur çelikoğlu, md

CONTACT

+90 538 54 92 848; ecenurcelikoglu14@gmail.com

yağmur acıyiyen, md

CONTACT

+905425669593; yagmuraciyiyen95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: md

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)