High- vs Standard-Dose Intravenous Magnesium for Acute Headache

Sponsor
University of Monastir
Study ID
NCT07779486
Status
Recruiting
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Conditions

  • Acute Headache
  • Cluster Headache
  • Migraine
  • Tension-type Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnesium Sulfate 2 grams — DRUG
    Participants assigned to this arm will receive intravenous magnesium sulfate 2 g diluted in 100 mL of 0.9% sodium chloride administered over 10-15 minutes, along with a matching placebo for paracetamol. Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.
  • Magnesium Sulfate 4 G — DRUG
    Participants assigned to this arm will receive intravenous magnesium sulfate 4 g diluted in 100 mL of 0.9% sodium chloride administered over 10-15 minutes, along with a matching placebo for paracetamol.. Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.
  • Paracetamol 1 g — DRUG
    Participants assigned to this arm will receive intravenous paracetamol 1 g administered over 10-15 minutes, along with a matching placebo for magnesium (100 mL of 0.9% sodium chloride). Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.

Study Details

Headache is one of the most common reasons for consultation in emergency departments and represents a significant cause of disability, particularly in patients with migraine and other primary headache disorders. Despite the availability of several analgesic treatments, including nonsteroidal anti-inflammatory drugs and paracetamol, pain relief is often incomplete, and a proportion of patients require additional rescue therapy. Magnesium sulfate has emerged as a potential therapeutic option in acute headache due to its role in modulating neuronal excitability, vascular tone, and pain-related neurotransmitter release. However, its efficacy as a standalone treatment, the optimal intravenous dose, and its comparative effectiveness versus standard therapy remain unclear. This randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of intravenous magnesium sulfate in the treatment of acute non-traumatic headache in the emergency department. Participants will be randomly assigned to receive either low-dose magnesium sulfate (2 g IV), high-dose magnesium sulfate (4 g IV), or intravenous paracetamol (1 g IV) as an active comparator. The primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS) at 60 minutes after treatment administration, as well as the proportion of patients achieving at least 50% pain reduction. Secondary outcomes include time course of pain relief, need for rescue medication, adverse events, patient satisfaction, and length of stay in the emergency department. In addition, the study will assess baseline ionized magnesium levels to explore their relationship with treatment response and evaluate whether magnesium levels may predict clinical efficacy. The results of this study may help clarify the role of intravenous magnesium sulfate in the management of acute headache and potentially improve treatment strategies in emergency settings.

Key Dates

First listed
Aug 21, 2026
Start date
Jun 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Magnesium Sulfate 2 g IV
    Intravenous magnesium sulfate administered as a single dose of 2 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
  • Active Comparator: Magnesium Sulfate 4 g IV
    Intravenous magnesium sulfate administered as a single dose of 4 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
  • Active Comparator: Paracetamol 1 g IV
    Intravenous paracetamol 1 g diluted in 100 mL, administered over 10-15 minutes.

Primary Outcome Measure

Change in Pain Intensity at 60 Minutes [ Time Frame: 60 minutes ]

Central Contacts

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