IV Magnesium in the Treatment of Acute Dysmenorrhea

NCT ID: NCT07248540

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magnesium Sulfate (2 Ampoules)

Intervention Type DRUG

Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes.

Intravenous Dexketoprofen

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

Group Type ACTIVE_COMPARATOR

Dexketoprofen

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Dexketoprofen

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Havva Betül Bacak

OTHER_GOV

Sponsor Role lead

Responsible Party

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Havva Betül Bacak

md

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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havva betül bacak, md

Role: PRINCIPAL_INVESTIGATOR

SBÜ Gaziosmanpaşa Training and Research Hospital

Locations

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SBÜ Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Outside of the US, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ecenur çelikoğlu, md

Role: CONTACT

+90 538 54 92 848

yağmur acıyiyen, md

Role: CONTACT

+905425669593

Facility Contacts

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yağmur acıyiyen, md

Role: primary

+9005425669593

ecenur çelikoğlu, md

Role: backup

+90 538 54 92 848

Other Identifiers

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GOP-IVMAG-DYSMENORRHEA

Identifier Type: -

Identifier Source: org_study_id

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