IV Magnesium in the Treatment of Acute Dysmenorrhea (IVMAG)

Havva Betül Bacak

Status: Enrolling

Conditions: Dysmenorrhea

Treatments: Drug: Magnesium Sulfate (2 Ampoules); Drug: Dexketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT07248540

GOP-IVMAG-DYSMENORRHEA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Magnesium Sulfate 2 Ampoules

Experimental group

Description:

Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes.

Treatment:

Drug: Magnesium Sulfate (2 Ampoules)

Intravenous Dexketoprofen

Active Comparator group

Description:

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

Treatment:

Drug: Dexketoprofen